Primary Location: TN-Nashville-DOT - VCH Doctor's Office Tower
Organization: Pediatric Infectious Disease 104606
Clinical Trials Specialist (Pediatric Infectious Disease)
·JOB SUMMARY:Coordinate review by Institutional Review Board of research proposals/protocols under which human subjects may be involved; compile protocol information, ensure compliance with federal regulations; support the activities of the Principal Investigator in accordance with federal, state, local, institutional, and any other appropriate guidelines, policies, and procedures.
- 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
· Bachelor's Degree (or equivalent experience) and < 1 year experience
· Day Shift/ Non-Exempt Position
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VUMC Recent Accomplishments
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
· US News & World Report: #1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology (Bill Wilkerson Center), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
· Truven Health Analytics: among the top 100 hospitals in the US
· 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 Middle Tennessee
· Nashville Business Journal: Middle Tennessee's healthiest employer
· American Hospital Association: among the 100 "Most Wired" medical systems in the US
- Occasional: Sitting: Remaining in seated position
- Occasional: Standing: Remaining on one's feet without moving.
- Occasional: Walking: Moving about on foot.
- Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
- Occasional: Push/Pull: Exerting force to move objects away from or toward.
- Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
- Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
- Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
- Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
- Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.
- Continuous: Communication: Expressing or exchanging written/verbal/electronic information.