Study Lead Coordinator

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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