Regulatory Coordinator

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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