Clinical Trials Specialist - Gastroenterology

The Division of Gastroenterology, Hepatology, and Nutrition is seeking a Clinical Trials Specialist.  The GI Clinical Trials team currently has over 150 studies in general GI disorders, inflammatory bowel disease, hepatology/liver disease and nutrition.  Our team is growing, and we are looking for a motivated, critical thinking individual with a passion for healthcare and innovation to join us as we work alongside physicians and industry leaders in the development of new treatment options.

• Coordinate protocol and patient consent form process
• Compile and analyze protocol information necessary to write IRB proposals and patient consent forms
• Formulate, design, and revise research proposal forms which are to be completed by research investigators who intend to do research involving human subjects; serve as a resource to these investigators and others who are engaged in research and/or undergoing audits.
• Write consent forms, conferring with PI and/or sponsor on language required. Ensure compliance with federal/IRB regulations
• Ensure approval obtained from IRB as required
• Review research proposals/protocols under which human subjects may be involved for conformity to university policy and Institutional Review Board requirements, and federal regulations.
• Review proposals for completeness of preparation and presentation of adequate and appropriately related information
• Ensure necessary forms, licenses, CVs, labs, are maintained and updated as required to meet regulatory guidelines
• Contact sponsoring company if find error in protocol
• Monitor accrual for study, ensuring compliance with protocol
• Coordinate approval process with Committees
• Communicate and coordinate with research investigators, monitors, IRB, and sponsors on requests for additional information and/or supportive documentation.
• Ensure approvals obtained from Bio and Radiation Safety Committee and IRB Committee, and other regulatory committees, as required
• Provide and maintain liaison with the university committee as the need arises; provide and maintain educational liaison with the investigators, PIs, and research analysts.
• Manage and submit adverse effects forms to the IRB for approval, as required.
• Compile annual reports for IRB on each research study. Provide new summary letter annually, as required.
• Compose and submit Investigational New Drug Applications to the FDA for drugs needing FDA approval. Inform FDA of all revisions to the study and obtain IRB approval of revisions.
• Maintain knowledge of federal regulations
• Read various books, regulations, periodicals, and newspapers to keep informed
• Attend conferences, seminars, symposiums, and classes
• Perform administrative duties in support of the studies
• Supervise clerical support staff to ensure that records and files are properly maintained and that the appropriate documentation is obtained when required
• Maintain database to track protocols, NCI registration, amendment renewals, new submissions, approvals, INDs, outside safety reports, adverse event forms and other data necessary to ensure compliance with regulatory guidelines.
• Manage cooperative and NCI registration
• Develop policies and procedures to support process
• Train new staff on process

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• Truven Health Analytics:   among the top 50 cardiovascular hospitals in the U.S.
• Becker's Hospital Review:   one of the "100 Greatest Hospitals in America"
• The Leapfrog Group:   grade "A" in Hospital Safety Score
• National Institutes of Health:   among the top 10 grant awardees for medical research in the US
• Magnet Recognition Program:   Vanderbilt nurses are the only group honored in Tennessee
• Nashville Business Journal:   Middle Tennessee's healthiest employer
• American Hospital Association:   among the 100 "Most Wired" medical systems in the US