Description
Clinical Trials Specialist
Vanderbilt Eye Institute
Role 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.
Key Responsibilities:
- 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
Position Qualifications:
Bachelor's Degree (or equivalent experience) and < 1 year experience
Department/Unit Summary:
At the Vanderbilt Eye Institute, we strive to make life better for adults and children with eye conditions including glaucoma, vision loss and diseases of the retina. We treat patients from across Tennessee and the Southeast. Our doctors, researchers and support staff use the latest technologies and methods, and we conduct vital vision research that translates to better treatments.
The Vanderbilt Eye Institute is a leader in quality eye care. We offer the latest technologies and methods while conducting innovative research to improve patients' lives and prevent vision loss.
Click here to learn more about the Vanderbilt Eye Institute
We work hard each day because your eyes are important to us.
The Vanderbilt Eye Institute attracts some of the most talented doctors and researchers in the country. Our subspecialty ophthalmologists have completed a minimum of one year of fellowship training after residency and are board eligible or board certified by the American Board of Ophthalmology.
Vanderbilt Eye Institute's award-winning research staff collaborates with our doctors as well as other Vanderbilt departments to pursue discoveries that enhance the vision of patients everywhere.
Position Shift:
Click here to view how Vanderbilt Health employees celebrated the difference they make each and every day: Celebrate 2019
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 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. It is a place 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.
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 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.
- Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.
- Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.
- The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.
- American Association for the Advancement of Science: The School of Medicine has 112 elected fellows
- Magnet Recognition Program: Received our third consecutive Magnet designations.
- National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement
- Human Rights Campaign Healthcare Equality Index: 6 th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
