Careers

[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Responsibilities:

• Responsible for management and evaluation of research programs,
• assuring objectives are met and integrity and quality of the research is maintained.
• Assures research is conducted in accordance with Good Clinical Practice Guidelines, federal/sponsor regulations and guidelines,
• Research protocols and Sponsor requirements are matched to research sites capabilities.
• Plans, implements and manages or provides oversight of the research from planning to completion, analysis and reporting.
• Responsible for or provides oversight for communication with the sponsor, IRB, DSMB, regulatory agencies and other research related entities.
• Functions as a departmental resource for research operations, a leader and role model, supervisor, consultant and educator.
• Ensures the most effective operation through performance monitoring, process improvement and coordination of processes across functions.
• Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes, and manages new research proposals, amendments, continuing review applications, adverse event reporting and document creation.
• Functions as a departmental resource, consultant and educator for the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations.
• Understands, implements, and transitions study protocols and is able to initiate multiple studies independently. (Able to identify when training is needed to safely and accurately perform or assess required procedures. Prepares, provides and/or participates in needed training). Problem solves when needed.
• Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies.
• Coordinates activities and gathers information from a variety of sources to achieve stated outcomes. Assures programs are compliant with reporting requirements. Identifies the need for and provides oversight, education and training when appropriate.
• Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
• Facilitates study and project related team meetings. Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors.Assists with the preparation of IND/IDE and regulatory related correspondence.
• Serves as an advocate for the organization by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.
• Utilizes or acquires knowledge of disease processes to accurately assign studies to the principal investigator, with adherence to all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations.
• Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research, literature searches, research seminars, in-services, etc.)
• Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
• Seeks to participate in research related programs, such as the Clinical/translational Research Staff Council and its activities by serving as a department representative, submitting issues or suggesting solutions, and reviewing Council meeting information, attending meetings open to research staff and by sharing information with other research personnel in the department.
• Facilitates process improvement in clinical research management to speed up study activation, implementation, conduct, close out and reporting.
• Defines and uses metrics to drive performance improvement. Shares metrics with investigators and superiors to demonstrate areas in need of improvement and track metrics to demonstrate effectiveness of improved processes
• Facilitates the education of departmental research staff regarding the importance of contributing to metrics, process improvement and responsible conduct of research
• Serves as a role model, mentor, supervisor and consultant to CRC. regulatory staff, and advises on workload, regulatory submissions and project work.
• Assists with orientation of new research staff by serving as an available resource, presenting at educational sessions, guiding new staff to attend useful educational sessions, e.g., IRB updates
• Develops tools to assist new and junior staff and keeps information current according to changing research requirements
• Assesses and checks work of CRC staff including regulatory submissions, source document creation, and binder development
• Assures the development of staff members through orientation, training programs and work experience. Strives to develop individualized professional development plan to guide staff to success, focusing on areas needing growth
• Exhibits strong leadership skills. Applies key concepts of facilitative leadership
• Assigns and reviews work; effectively prioritizes tasks and work assignments. Delegates tasks as appropriate and follows up to assure completion. Plans, organizes, and completes study start up in an efficient manner.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Duties & Responsibilities:

• Review clinical studies and understand study specifics and eligibility requirements
• Serve as primary contact between patient, doctor, clinical research coordinators and investigators
• Set screening criteria and communicate with existing patients from internal database to pre-screen for study eligibility
• Support the development of recruitment strategies, branding, and campaign materials including television, radio, and digital marketing
• Manage & track outreach efforts (letters out, ad campaigns, calls, emails, etc.)
• Develop outreach materials including letters and pamphlets
• Partner with outside vendors and identify potential opportunities to recruit external patients
• Performs direct recruiting/advertising activities (involving the setup and coordination of daily recruitment table activities) for multiple research projects using advertisements approved by the appropriate Institutional Review Board (IRB) using media available and feasible for the studies open for recruitment.
• Ensures up-to-date recruitment materials/advertisements are publicly available via all approved platforms (i.e.; website, social media, etc.)
• Demonstrates excellent interpersonal communication and collaborates well with others as part of a multi-disciplinary team to include Principal Investigators, Clinical Research Coordinators, Clinical Research Assistants, Data Managers, and other center staff.
• Works with the study team to draft and update recruitment fliers, recruitment scripts, and other recruitment related materials; helps team keep track of expiration dates of various recruiting documents.
• Conducts IRB-approved recruitment activities, which may include manning a recruitment table and conducting scripted telephone interviews with potential participants.
• Attends recruitment meetings with study staff, clinicians, and/or potential participants.
• Schedules consent/screening meetings between potential participants and study team members.
• Creates, updates, and maintains a recruitment database.
• Develops clinical contacts throughout for the purpose of updating clinicians regarding recruitment for ongoing studies and securing new recruitment table locations.
• Works with study team to develop working knowledge of all ongoing studies and effectively communicates the design and inclusion criteria of these studies to potential participants.

We are looking for Patient Recruitment Specialists with sales experience to join our Patient Experience team. Under the supervision of the Head of Patient Experience, the Patient Recruitment Specialist will be responsible for all recruitment related activities for assigned clinical trials. This includes but is not limited to mastery of protocol-specific inclusion/exclusion criteria, participation in the development of recruitment strategies and plans, and the tracking of recruitment results. The Patient Recruitment Specialist will mainly be responsible for calling potential study participants, getting them excited about participating in clinical research, and working with research sites to schedule potential participants for on-site visits. If you are a curious, motivated person and are looking to make an immediate impact at an exciting startup, please get in touch! About You and The Role:

• Make 40-50+ outbound calls a day, responding to patients that are interested in participating in a clinical trial; assess preliminary subject eligibility against protocol specific inclusion and exclusion criteria
• Answer incoming calls from potential study patients and assess preliminary subject eligibility against protocol specific inclusion and exclusion criteria
• Develop and maintain a working knowledge of assigned medical indications
• Review patient database and other electronic platforms as required to identify potential study patients and initiate contact
• Ensure accurate collection and entry of patient information into the relevant databases while on the phone
• Ensure courteous and efficient service is provided to all callers
• Support other members of your team as well as cross-functional team members
• Attend and contribute to department meetings.

Your Skills:

• Bachelor’s degree, Associate’s degree or equivalent with a passion for communicating to people.
• Prior history delivering excellent customer service is required; call center experience a plus.
• Documentation in a customer service environment, medical documentation is preferred.
• Be an outgoing individual who is comfortable making connections with new people.
• Medical terminology a plus.
• Bilingual (Spanish/English) a plus.
• Prior inside sales experience a plus.
• Possess exceptional organizational skills and attention to details.
• Display excellent verbal and written communication skills.
• Able to quickly adapt to changes in responsibilities, workloads, and priorities.
• Be a fast learner with the capacity to retain and differentiate key enrollment criteria across clinical trials.
• Demonstrate a focus on process improvement and be capable of articulating ideas for improving efficiency and maximizing results.
• Possess well-developed interpersonal skills and an ability to work well independently, as well as with co-workers, peers, supervisor, and external customers.
• Able to maintain confidentiality with HIPAA guidelines, patient information, and other sensitive information.
• Demonstrate professionalism, sense of urgency, and self-motivation to achieve required metrics.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Role: Provides service to patient either pre-appointment, during or post appointment with occasional guidance. Responsibilities may include inbound/outbound telephone calls, appointment scheduling, process of insurance updates and patient check in/out. Navigates more complex patients to include scheduling with multiple services or coordination with outside facilities or providers. Key Responsibilities:

• Conducts patient check-in and check-out.
• Coordinates any follow-up appointments or procedures required for patient.
• Schedules appointments, procedures or surgery through clinical communication or direct request.
• Provides positive first impressions utilizing customer service skills.
• Works with patients and/or outside facilities to ensure all administrative tasks, including; referrals, medical records and documentation, orders and consults have been received and ready to view prior to patient visit.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

Technical Capabilities:

• Customer Service (Intermediate): - A continuing focus on the needs and requirements of customers, anticipating their needs, remaining sensitive to customers while performing services for them, responsive to customer needs.
• Patient Documentation (Novice): - The ability to receive and record patient information.
• Patient Scheduling (Novice): - The ability to coordinate and schedule patient appointments, surgeries and other office visits with various computer systems in the hospital or clinic.
• Medical Terminology & Documentation (Novice): - The ability to comprehend medical terminology and documentation in an office, or surgical setting.

Core Accountabilities:

• Organizational Impact: Performs tasks that are typically routine that may impact team's performance with occasional guidance.
• Problem Solving/ Complexity of work: Utilizes some discretion and research to solve routine problems.
• Breadth of Knowledge: Applies knowledge of standards, established processes and procedure that apply to your own job.
• Team Interaction: Provides guidance to entry level co-workers.

Core Capabilities: Supporting Colleagues (S2):

• Develops Self and Others: Continuously improves own skills by identifying development opportunities.
• Builds and Maintains Relationships : Seeks to understand colleagues priorities, working styles and develops relationships across areas.
• Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner.

Delivering Excellent Services (S2):

• Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service.
• Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner.
• Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support.

Ensuring High Quality (S2):

• Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards.
• Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond.
• Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department.

Managing Resources Effectively (S2):

• Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service.
• Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources.
• Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error.

Fostering Innovation (S2):

• Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.
• Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action.
• Adapts to Change: Embraces change by keeping an open mind to changing plans and incorporates change instructions into own area of work.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Job Summary Responsible for management and evaluation of research programs, assuring objectives are met and integrity and quality of the research is maintained. Assures research is conducted in accordance with Good Clinical Practice Guidelines, federal/sponsor regulations and guidelines, Vanderbilt Policy and Procedure, research protocols and sponsor requirements. Plans, implements and manages or provides oversight of the research from planning to completion, analysis and reporting. Responsible for or provides oversight for communication with the sponsor, IRB, DSMB, regulatory agencies and other research related entities. Functions as a departmental resource for research operations, a leader and role model, supervisor, consultant and educator. Ensures the most effective operation through program development, performance monitoring, process improvement and coordination of processes across functions. Additional Key Elements/ Responsibilities:

• Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes, and manages new research proposals, amendments, continuing review applications, adverse event reporting and document creation.
• Functions as a departmental resource, consultant and educator for the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations.
• Functions as a departmental resource regarding the policies and procedures and requirements of Vanderbilt departments involved in the approval and proficient and compliant conduct of research (IRB, grants, contracts, finance, etc.)
• Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently. (Able to identify when training is needed to safely and accurately perform or assess required procedures. Prepares, provides and/or participates in needed training). Problem solves when needed.
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in or provides oversight of periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures.
• Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies.
• Coordinates activities and gathers information from a variety of sources to achieve stated outcomes. Assures programs are compliant with reporting requirements. Identifies the need for and provides oversight, education and training when appropriate.
• Responsible for project completion processes including timely study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing periodic quality checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
• Facilitates study and project related team meetings. Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors.
• Assists with the preparation of IND/IDE and regulatory related correspondence.
• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.
• Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator, DSMB and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations.
• Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research, literature searches, research seminars, in-services, etc.)
• Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
• Engages in a minimum of 15 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification
• Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
• Seeks to participate in research related programs, such as the Clinical/translational Research Staff Council and its activities by serving as a department representative, submitting issues or suggesting solutions, and reviewing Council meeting information, attending meetings open to research staff and by sharing information with other research personnel in the department.
• Participates and presents in local, national and international conferences. Actively participates in publishing opportunities. Develops and achieves personal and professional goals.
• Facilitates process improvement in clinical research management to speed up study activation, implementation, conduct, close out and reporting.
• Defines and uses metrics to drive performance improvement. Shares metrics with investigators and superiors to demonstrate areas in need of improvement and track metrics to demonstrate effectiveness of improved processes
• Facilitates the education of departmental research staff regarding the importance of contributing to metrics, process improvement and responsible conduct of research
• Serves as a role model, mentor, supervisor and consultant to CTRC III regulatory staff and advises on workload, regulatory submissions and project work.
• Assists with orientation of new research staff by serving as an available resource, presenting at educational sessions, guiding new staff to attend useful educational sessions, e.g., IRB updates
• Develops tools to assist new and junior staff and keeps information current according to changing research requirements
• Assesses and checks work of CTRC III staff including regulatory submissions, source document creation, and binder development
• Assures the development of staff members through orientation, training programs and work experience. Strives to develop individualized professional development plan to guide staff to success, focusing on areas needing growth
• Exhibits strong leadership skills. Applies key concepts of facilitative leadership
• Assigns and reviews work; effectively prioritizes tasks and work assignments. Delegates tasks as appropriate and follows up to assure completion. Plans, organizes, and completes projects in an efficient manner

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Coordinate, implement and analyze quality processes that ensure clinical research compliance with regulatory and Quality Assurance standards. Along with ensuring compliance amongst research team members. Compliance Officer role and responsibilities:

• Supports the development of programs and plans to support quality improvement.
• Demonstrates quality improvement process-management skills.
• Demonstrate proficiency in identifying, defining, and analyzing goals.
• Analyze compliance data and prepare audit reports and summaries of findings.
• Oversee training for all protocols as well as requirements for regulations.
• Ensure that the safety, welfare and dignity of subjects are not compromised.
• Ensure that the office, scientific and medical standards provided are met.

Quality Assurance:

• Coordinate, implement and analyze quality processes that ensure clinical research compliance with regulatory and Quality Assurance standards.
• Organize and perform random, for-cause, and regulatory committee-requested audits of clinical research studies, as appropriate, to ensure compliance with applicable regulations and guidelines.
• Support the development of clinical research programs and plans to support quality improvement.
• Develop and implement clinical research quality improvement projects and initiatives and serve as a member of project teams.
• Serve as a resource for clinical research policy and standards interpretation and ensure utilization in operations.
• Maintain a current knowledge of federal and state laws, as well as regulations and guidelines governing human subjects research.
• Maintain company HIPAA manuals and ensure all team members have reviewed and signed off on it.
• Ensure each staff member has a current Good Clinical Practices (GCP), HIPAA and Human Subject Protection (HSP) certificates.
• Ensure the subject charts have been QA’d and are up-to-date and audit ready.
• Ensure monitoring visits and sponsor/FDA audits are completed successfully.
• Ensure that all work is carried out in strict adherence with relevant protocols, SOP's, and in compliance with ICH/GCP guidelines. Ensure that managers/research staff is trained and compliant with SOP's and Skills checks. Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.

Process Improvement:

• Participate in clinical research process improvement projects and tasks including providing expertise and guidance during organizational meetings.
• Develop and update clinical research documentation that can be communicated efficiently to all levels within the project.
• Coordinate timely communication of quality management initiatives.
• Summarize data in a format that will facilitate identification and prioritization of improvement initiatives.
• Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest clinical research standards possible. This includes training with staff development for on-site and off-site personnel, as required.
• Support the team and investigators in overall conduct of trials.

Communication:

• Communicate with internal and external customers.
• Meet with leadership and staff to elicit training, education and compliance requirements.
• Develop audience-appropriate presentations regarding clinical research quality and compliance issues and implementations.
• Perform routine compliance reviews related to the clinical trials and IRB activities.
• Investigate allegations and findings of non-compliance. Report potential serious or continuing non-compliance with applicable regulations or institutional policies and other leaders as appropriate. Provide Principal Investigators with quality improvement recommendations to ensure that research is conducted in compliance with regulations and approved protocols.
• Prepare written reports detailing observations, regulatory risks, recommendations, and any other actions necessary to bring the research or IRB activity into compliance.
• Assist investigators and the institution in preparations for external audits and inspections by sponsors, grantors, accrediting bodies, and regulatory authorities. Provide education on expectations and how best to prepare and organize materials and interact with the auditors or inspectors. Interview personnel and review records in advance to identify possible areas of concern so that the issues can be proactively addressed.
• Provide support and guidance to exit interviews. Assist in the development of corrective actions and written responses as warranted.
• Demonstrate analytical skills to gather, interpret, organize and present compliance-related data and work collaboratively with interdisciplinary teams of external and internal individuals.

Compliance Program:

• Organize and implement the company’s Compliance Program.
• Prepare the Compliance program agenda for 2 months out in advance to ensure we have proper coverage in case of any cancellations.
• Schedule Compliance Trainings bi-weekly on Wednesdays from 12pm-1pm EST and email the reminder 3 days before the meeting and again the morning of the training. Any training slides or documents for the presentation should be sent out with the invitation as well.
• Attendance should be maintained and all attendees shall sign a sign in sheet to confirm their attendance.
• Following each training session, a quiz on that topic should be generated and sent out to all attendees.
• Certificates are to be provided after someone successfully passes the quiz.
• The recorded trainings need to be maintained on the Company’s Training Portal.
• Oversee training for all protocols as well as requirements for regulations.

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• Develops and maintains quality monitoring plans for assigned programs. Executes and/or oversees implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
• Ensures agreed upon deliverables are completed within the timeframe established, including but not limited to, review and assessment of Quality Risk Management reports; coordination of quality risk mitigation plans for identified issues; quality reviews of key clinical trial documents, and review and planning of submission activities as needed.
• Supports Due Diligence activities, as requested
• Provides Good Clinical Practices (GCP) guidance to workgroups and to business partners.
• Ensure interpretation and consistency with compliance guidance provided. Assists in the facilitation of inspections by regulatory authorities for GCP

• Develops Quality Monitoring Plans and performs/oversees performance of quality monitoring activities for assigned projects or other projects/tasks, as assigned, according to agreed upon deliverables and established timelines.
• Provide ongoing compliance support to business partners, including but not limited to:
  • Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk. Collaborates with applicable team members to develop risk mitigation plans.
  • Providing compliance support in the management and implementation of quality risk mitigation and inspection readiness actions
  • Collaborating with the Clinical Team business partners to share audit/inspection observations for lessons learned across protocol, and/or program, and working with appropriate groups to implement Corrective Action Plans (CAPAs).
• Provide compliance direction/support to applicable clinical team members on an ongoing basis.
• Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities.
• Supports special projects, as assigned by supervisor. May mentor new employees.
• Provides appropriate support to assigned cross-functional workgroups.
• Responds independently to GCP-related compliance inquiries from other departments. Confers with quality professional staff when contacted for pro-active consultation to provide regulatory insight.
• Manages inspection preparation activities and supports business during health authority inspections

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Duties & Responsibilities: Under general direction and in accordance with all applicable federal, state and local laws/regulations and company policies, procedures and guidelines, this position:

• Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
• Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• May serve as the primary contact for clinical trial sites (e.g. site management);
• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• Oversee the development and execution of Investigator agreements and trial payments;
• Responsible for clinical data review to prepare for statistical analyses and publications;
• If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
• If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
• Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
• Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Track and manage assigned project budgets to ensure adherence to business plans;
• Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;
• Develop a strong understanding of the pipeline, product portfolio and business needs;
• May serve as the clinical representative on a New Product Development team;
• May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;
• Perform other duties assigned as needed;
• Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but require minimal guidance for complex situations.

Experience And Education: Education

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience

• BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
• Previous experience in clinical research or equivalent is required.
• Experience working well with cross-functional teams is required.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background a plus.
• Experience managing projects a plus.
• Medical device experience highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS Functional and Technical Competencies:

• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects;
• Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral communication skills;
• Demonstrate competencies in the following area are required:
  • Behave and lead in a professional and ethical manner
  • Advanced technical writing skills
  • Advanced project management skills with ability to handle multiple projects

Leadership Competencies:

• Ability to lead small study teams to deliver critical milestones, as may be assigned.
• Leadership required in alignment with company Leadership Imperatives:
• Connect – Develop strong collaborative relationships with key internal and external stakeholders.
• Shape - Make recommendations for and actively participate and lead in departmental process improvement activities.
• Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
• Deliver - Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Duties & Responsibilities:

• Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, adverse event reports, budgets, and D&H accounts.
• Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations.
• Advanced knowledge of the policies and procedures and requirements of Vanderbilt departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and then assure compliance throughout the research process.
• Advanced knowledge and understanding of the management and implementation of clinical/translational research operations.
• Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures. Works collaboratively with other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures. Problem solves when needed.
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Participates in data quality assurance reviews.
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required).
• Participates in the determination of eligibility and recruits candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation in an accurate and timely manner.
• Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools.
• Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes.
• Receives and tracks receipt and status of study specimens from multiple sites. Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation.
• Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation.
• With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies.
• With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to investigators, department administration and funding agencies.
• Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures.
• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.
• With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation
• Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial.
• Engages in open communication with participants by providing them with contact information and being available to answer their calls.
• Performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies.
• Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations.
• Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research seminars, in-services, etc.)
• Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work.
• Engages in a minimum of 15 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification.
• Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor.
• Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by serving as a department representative, submitting issues or suggesting solutions, and reviewing CTRSC meeting Council information summaries, attending meetings open to research staff and by sharing information with other research personnel.
• Actively seeks new learning opportunities, seeing continued learning as part of work. Develops and achieves personal and professional goals.
• Serves as a role model, mentor and consultant.
• Participates in groups within the institution to contribute to the improvement and development of the research environment.
• Participates at local professional meetings.
• Assesses for and implements process improvement initiatives within a clinical/translational trial and a department to assure research quality, and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient study reporting.
• Supports process improvement in clinical/translational research management to speed up study activation, implementation, conduct, close out, and reporting.
• Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes.
• Networks with other research departments and colleagues to share best practices.
• Develops recruitment and retention strategies to improve study performance.
• Continually revises operating procedures to assure quality and human subjects protection.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Responsible for management and organization and conduct of all research sites. Clinical Site Operations Manager role and responsibilities:

• Accountable for meeting accrual metrics (actual vs. targeted enrollment) and leads to ensure timely, and efficient initiation and completion of all clinical trials.
• For recruitment, provide leadership of EMR-review teams and functions to ensure optimal research participant recruitment for all research teams.
• Obtain site EMR access for all necessary research staff.
• Coordinate with the CRCs on the recruitment efforts.
• Manages all duties necessary for effective and compliant clinical research study coordination for multiple therapeutic areas, including planning, organizing, and managing all activities related to clinical research operations and execution of timelines.
• Maintains awareness of overall development in the field of clinical research and ensures that staff remains current on clinical monitoring developments.
• Maintains an awareness of company policies to effectively represent the company perspective to clinical staff.
• Collaborates with other department and/or functional groups to ensure consistency of processes.
• Supports management in assuring professionalism and adherence to company principles of Customer Service and Company Culture.
• Supports implementation of new company initiatives in terms of process improvement or new technology related to clinical research.
• Directly or indirectly supervise study staff by ensuring compliance and address any employee compliance issue or concerns as needed.
• Demonstrate ability to lead by example and to encourage team members to seek solutions.
• Review and revision of departmental SOPs, working practices, and policies.
• Development of strategic departmental goals which correlate with corporate goals and formalize departmental action plans to meet those goals.
• Process Improvement Plans and other special projects as required by the department.
• Develops strategies for efficient study conduct, data collection, subject management and safety monitoring. Coordinates efforts interdepartmentally to accomplish these strategies.
• Assist with required study startup training, documentation, start-up tasks and timelines on assigned study protocols.
• Conducts field evaluation visits with staff at sites to check compliance.
• Collaborate with corporate teams to ensure staffing, start-up, and trial goals are met.
• Maintain effective, courteous and ongoing communication with staff, sponsor, research participants, and PI during the course of trials.
• Assists with organizing and conducting Staff Meetings at regular intervals and addresses issues discovered at meetings.
• Coach, train, and support research staff.
• Ensure staffing and resource needs are met on both day-to-day and strategic basis.
• Assesses and organizes appropriate training requirements for research staff
• Communicates staff training needs to Director.
• Assists Director to create and deliver new department initiatives, improvement plans or training.
• Ensure that the staff is adequately trained to meet the quality standards and forecasted workload.
• Monitors and records subsequent performance to assess the effects of training on efficiency.
• Communicates staff increase and equipment needs to HQ.
• Oversee the transportation, scheduling and recruitment departments.
• Manage site workflow and processes.
• Coordinate ordering office supplies for the sites as needed.
• Ensure adequate space is available at the sites for storage of study supplies and equipment.
• Address any employee compliance issues or concerns as needed.
• Assist with PSV and SIV scheduling for the sites.
• Obtain signatures on regulatory documents as needed by coordinating with the regulatory department.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Research Clinical Director, oversees the clinical research process of the clinical staff from initiation of research projects, study design, implementation and coordination to completion, monitoring and analyzing data. Director of Clinical Research role and responsibilities:

• Provides periodic status reports and updates of clinical research output and performance to senior management on a regular basis. Collaborates with staff in other departments within the organization to construct, implement, and achieve performance goals and methods required for accurate and timely completion of clinical research projects.
• Supervises clinical research staff to ensure accurate/appropriate completion of study protocols and analysis for study investigators. Responsible for organizing and facilitating meetings/mentoring sessions with research support staff including research coordinator staff meetings to further educate the research team and other staff in research methods.
• Oversees database integrity and security of clinical research. Monitors the input of data and maintenance of specified databases for projects for accurate reporting. Provides data reports in an acceptable format to recipients and assist in analyzing the data. Interacts with research subjects and their families to communicate procedures and significance of the study and recruit patients for research studies, obtaining their informed consents to participate in studies, acts as patient advocate.
• Serves as a liaison for clinical research to ensure adequate feedback is given and the build is optimized for the medical staff and research staff to increase efficiency in the collection of data for research purposes.
• Attends national professional meetings each year and participates in study group meetings.
• Actively participates in educational activities and staff meetings and continuously explores ways to gain knowledge and improve job performance.
• Develop operating procedures and ensure that the entire research team follows those procedures.
• Create good overall guidelines for clinical research and ensure that the guidelines are followed.
• Help balance budgets and oversee the management of the clinical research team.
• Ensure that all federal and state regulations are followed completely.
• Present progress reports and strategies to management.
• Strong ability to direct and manage a team to fulfill all projects on time and within the budget while providing rich insights to clients.
• Must be able to spot talent quickly.
• Needs to have the skill set to be able to take a challenging problem and figure out how to approach it and what kind of partners they need to bring together.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Responsibilities: Participates in clinical research and provide clinical pharmacy services and oversight for safe use of medication. This includes prescribing, dispensing, administering, and monitoring of medications. This may include, but is not limited to:

• Monitors patients for therapeutic and/or toxic response to medication
• Ensures continuity of care and access with all medications
• Provides support to improve safety and to reduce risk to patients treated in clinical research programs assigned.
• Proactively assesses and ensures medication adherence and makes appropriate documentation on the inquiry
• Collaborates with Infusion Pharmacy staff to provide continuity of care on medication infusion related issues as necessary
• Develop and participate in pharmacy-related research projects and quality improvement initiatives
• Maintains familiarity with all departmental programs and works as integral part of the pharmacy team.
• Maintains responsibility for clinical investigational drug trials.
• Reviews protocols for clinical investigational drug trials, as required.
• Liaises with principal investigators and/or trial coordinators/research assistants to establish pharmacy’s role
• Communicates with, and trains staff anticipated to participate in any aspect of the clinical investigational drug trial.
• Maintains a pharmacy binder which contains a study summary, protocol, dispensing procedures, completed samples of required paperwork, dispensing checklist, and any other relevant materials for each investigational trial.
• Maintains and coordinates distribution of an up-to-date investigational drug trials list, as scheduled.
• Maintains responsibility for the management of the inventory for clinical investigational drug trials; orders, replaces and returns study materials, as required.
• Assists in ensuring the participation of the pharmacy department in all clinical trials which involve drugs.
• Provides accurate and efficient dispensing of medication.
• Monitors pharmacy activities, on a daily basis, to ensure adherence to study protocols and dispensing procedures.
• Attends and contributes to interdisciplinary team meetings relating to clinical investigational drug trials.
• Facilitates rapport between the Department of Pharmacy, principal investigators, clinical trial coordinators, research assistants and trial sponsors.
• Consults with other pharmacy personnel, to obtain information/expertise in support of the investigational drug trials, as required.
• Effectively communicates with colleagues, and allied health professionals.
• Liaises with external agencies/organizations, as required.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]A Business Development Manager, or Business Development Executive, is responsible for overseeing the implementation of business objectives among their company’s marketing and business development professionals. Business Development Manager role and responsibilities:

• Maintain current client relationship and identifying areas for potential clients.
• Contacting potential clients to establish a business relationship and meet with them.
• Develop new methods and improve efficacy through various methods
• Research the latest in the business industry and creating new opportunities to expand business.
• Collaborate with recruitment team to ensure recruitment goals are met.
• Strong understanding of company services as well as business position and competition to keep business competitive
• Drive prospecting and acquisition of new business
• Drive negotiation of new contracts and agreements with industry clients
• Manage the execution of projects from initiation through completion
• Work cross-functionally to manage and deliver goal commitments
• Support business development strategy and initiatives
• Serve as a member of senior leadership team in the Company.
• Develop and execute business development opportunities including business agreements and/or partnerships.
• Lead a cross functional team of clinical research personnel, project management, legal and finance to evaluate opportunities, develop relationships with external partners.
• Assist in the management responsibility for the company’s deal making.
• Provide guidance to the company’s growing pipeline.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]Responsibilities include:

• Support Physicians, Research Manager and Clinical Study Staff with study specific administrative tasks.
• Supports laboratory activities related to laboratory testing (phlebotomy, specimen collection, computer order entry and specimen processing) to ensure accurate result reporting.
• Consent potential participants in clinical trials.
• Provide protection of sensitive health information, study data, and proprietary information.
• Collect pertinent visit assessment details ensuring accuracy of all records connected with each research participant.
• Assist in obtaining vital signs and electrocardiograms.
• Obtain, process and ship laboratory specimens to central laboratories.
• Provide professional input regarding subject visits, assessments, evaluations and determination of eligibility for study participation.
• Assist with transcription/data entry and review of completed Source Documents and Case Report Forms (CRFs).
• Complete all source documents, Case Report Forms (CRFs) and data entry into research management systems accurately and timely to assure compliance with study sponsors.
• Respond to queries generated in Electronic Data Capture (EDC) systems.
• Ensure compliance with study protocols and SOPs.
• Coordinate pick-up of outgoing packages with appropriate vendors.
• Prepare visit documents and ancillary supplies required for upcoming visits.
• Provide input during team discussions and meetings.
• Organize and assist with the maintenance of study logs.
• Organize incoming faxes and participant binders.
• Monitor temperature-controlled study products.
• File study specific documents on a daily basis.
• Work to create a positive work culture.
• Perform other related duties incidental to the work described herein.

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]The position of Director of Clinical Administration is to provide administrative and clinical operations leadership for Revival Research Institute, LLC. The Director of Clinical Administration will provide supervision and guidance for the day-to-day needs and development of Revival Research Institute’s clinical program and facilities, while supporting the mission and goals of Revival Research Institute. Duties include:

• Provide leadership and guidance in all aspects of clinical operations, including management of personnel, patient recruitment, financial resources, space, patient flow, and risk management
• Work closely with the management to maintain quality assurance, financial stability, and process improvement
• Assist in recruitment of subjects into various clinical trials
• Coordinate clinical coverage for routine operation and after-hours emergency
• Provide guidance and management for the compliance programs
• Collaborate with external providers and organizations to develop and expand the Revival’s clinical program.
• Ensure continuous compliance with clinical affiliation agreements with external entities
• Ensure continuous compliance with all regulatory requirements
• Remain active in clinical research organizations.
• Adopt and advance the mission and goals of Revival Research Institute
• Participate in continuous improvement of curriculum in collaboration with the assessment and curriculum committees.
• Solicit feedback from subjects and colleagues to evaluate effectiveness in operations
• Other duties as assigned or as needs arise relating to the effective implementation of the program
• Providing training and ongoing developmental support
• Collaborate with corporate team to implement all required policies and procedures
• Identify opportunities and implement changes to improve the processes
• Oversee the overall execution of the assigned processes with focus on quality, budget and timelines, including making decisions or recommending operational strategies in support of achieving clinical program objectives
• Oversee and direct goals and objectives, standards, and policies and procedures to achieve high-quality patient care and improved patient outcomes in accordance with the organization’s strategic plan
• Actively involvement in invoicing, financial reconciliation and accounting
• Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest clinical research standards possible. This includes training with staff development for on-site and off-site personnel, as required
• Provides periodic status reports and updates of clinical research output and performance to senior management on a regular basis. Collaborates with staff in other departments within the organization to construct, implement, and achieve performance goals and methods required for accurate and timely completion of clinical research projects.
• Actively participates in educational activities and staff meetings and continuously explores ways to gain knowledge and improve job performance
• Strong ability to direct and manage a team to fulfill all projects on time and within the budget while providing rich insights
• Needs to have the skill set to be able to take a challenging problem and figure out how to approach it and what kind of partners they need to bring together
• Ensure that all work is carried out in strict adherence with relevant protocols, SOP's, and in compliance with ICH/GCP guidelines. Ensure that managers/research staff is trained and compliant with SOP's and Skills checks. Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP

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[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none"][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]The Corporate Operations Manager (COM) provides a variety of management and professional support across the organization with an emphasis on planning, performance management, operational efficiency and effectiveness and organizational development. Corporate Operations Manager role and responsibilities:

• Lead in completing this process ensuring that a comprehensive set of operational policies are in place, staff have been trained and compliance is verified.
• Responsible for maintenance of policies and procedures on an ongoing basis.
• Review and update existing policies and procedures as well as identifying need for and developing new policies and procedures to reflect the needs of a growing and dynamic organization.
• Coordinate and manage role to ensure follow through, completion and maintenance of policies, procedures and projects.
• Conduct analysis to support a variety of planning and performance management tasks.
• Develop and maintain a database of all HQ contracts and agreements so that key data (start/end dates; organizational owner; contract value; usernames/passwords; etc) are centrally located and accessible to management.
• Provide regular support for meetings (e.g., help to develop agenda, recruit staff to take notes if necessary, develop slide decks, share meeting materials for benefit of travelers, etc)
• Ensure staffing and resource needs are met on both day-to-day and strategic basis.
• Accountability for operational issues and customer interaction.
• Ensure personnel are in compliance with respect to company policy, procedure, safety and quality guidelines.
• Meet with customer and all parties involved to identify, evaluate and correct any performance related issues.
• Act as a liaison between the company and customers forming and maintaining positive relationships.

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