Manager, Clinical Trials

Discover Vanderbilt University Medical Center:  Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of diverse individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and where your diversity of culture, thinking, learning, and leading is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization:

VICC - Clinical Trials

Job Summary:

Leads research activities for the departments research initiatives. Manages and coordinates research studies and personnel.

Act as project manager for each study within their portfolio
Act as primary point of contact with the sponsor from feasibility through permanent closure
Collaborate/facilitate operations with study team and ancillary departments primarily in startup but throughout the life of the study
Lead study team and external stakeholders through startup
Stay abreast of status of each element of the study and escalate holdups and potential obstacles (primarily in startup but throughout the life of the study)
Prepare for and present in internal stakeholder meetings

Preferred experience:
Clinical trials experience, preferably cancer

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KEY RESPONSIBILITIES
• Independently manage budgetary responsibilities and research contracts for clinical research faculty members
• Track budget for federal and non-federal grants, development funds and clinical trial studies
• Develop, negotiate and maintain contract administration
• Audit and review accounts throughout the year to ensure compliance with the NIH and prepare monthly variance analysis reports and track CME expenditures
• Manages staff supporting Clinical Trials/ Research activities for the department.
• Oversee implementation of reports for personnel and investigator funding
• Serve as liaison between the IRB and the department, obtaining necessary approvals for research projects
• May work other departments to develop and implement programs in support of the clinical trials/ research activities.
• Provide instruction on research protocols including interpretation of test results, observations, and related study data to physicians, nurses, professors, teachers, and technician involved.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.


TECHNICAL CAPABILITIES
• Medical Records Management (Expert): Knowledge of how and where to store and maintain basic records associated with job assignments.
• Research Administration (Expert): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.
• Laboratory Practices (Expert): Is a recognized expert and authority in laboratory practices. Occupies the position that is the last internal resource for support or direction. Expected, as a result of the position, to have the ultimate knowledge, control, influence, and/or jurisdiction in laboratory practices. Demonstrates industry leadership in outside professional organizations and forums. Takes a lead role in developing best practices for the organization.

Our Academic Enterprise is one of the nation’s longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.

World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.

Aligning with Vanderbilt Health’s Strategic Directions, the Office of Research pro