Vanderbilt University Medical Center Healthcare Research Regulatory Affairs Specialist in Nashville, Tennessee
Healthcare Research Regulatory Affairs Specialist - 2103671
Job : Research
Primary Location : TN-Nashville-2525 West End Ave
Organization : Human Research Protection Prog 104064
Shift: : First Shift
The Healthcare Research Regulatory Affairs Specialist serves as the central resource to investigators to assist with and provide regulatory guidance through experience and knowledge of related federal regulations (FDA). The Healthcare Research Regulatory Affairs Specialist closely partners with investigators and internal departments to deliver safe and effective research designs for clinical trials in line with institutional policies and procedures, and federal regulations. This may include study planning, start-up and implementation, Investigational New Drug (IND) applications, drug development and regulatory issues. Participates in training faculty and staff in the research community, as well as the development and revision of educational programs.
The Vanderbilt Institute for Clinical & Translational Research (VICTR) is Vanderbilt’s virtual home for clinical and translational research. Supported by Vanderbilt University Medical Center’s Office of Research and the NIH-sponsored Clinical and Translational Service Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to patient care. VICTR functions to help researchers and clinicians do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers. For more information, please visit https://victr.vumc.org/ .
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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.
Provides consultation to determine if an IND/IDE is needed for proposed research and tracks new and ongoing INDs and IDEs.
Assists researchers with FDA submissions and study design questions, ensures the quality of FDA applications, protocols, submissions and documentation, and maintains Institutional files for all FDA correspondence.
Offers training for protocol development/review, and provides tools, templates, and guidance for obtaining and maintaining an IND/IDE clinical trial.
Navigates VUMC researchers through operationalizing study start-up, management, and closure.
The responsibilities listed are a general overview of the position and additional duties may be assigned.
REGULATORY ACTIVITIES (INTERMEDIATE)
- Utilize knowledge of federal regulations and institutional procedures to accurately and effectively
serve as a resource on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, study design, marketing, FDA submissions, HRPP submissions, and manuscript preparations. Advise investigators on preclinical and regulatory pathway most appropriate for specific IND development. Assist investigators in developing FDA applications and protocols and determining types of regulatory submissions and internal documentation required in diverse situations. Coordinate, prepare and review regulatory submissions/documents to the appropriate regulatory body. Actively support researchers in communications with the FDA by scheduling meetings and preparing and submitting communications per regulations. Identify and assist with interpretation of relevant regulations, guidance documents, and consensus standards. Collaborate, as needed, with other individuals assisting investigators in research activities throughout the Institution. Actively participate in project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes. Interface and partner with regulatory bodies that influence policies and regulations that affect research including the Vanderbilt Human Protection Program, Risk Management, General Counsel, Contracts Management, Office of Sponsored Programs, and Department of Finance.
QUALITY ASSURANCE (INTERMEDIATE)
- Utilize strong working knowledge of federal regulations and institutional procedures to assist investigators in the development of quality metrics and management of an effective quality assurance process to support compliance with federal regulations for methods, facilities, and controls. Provide ongoing assistance, consultation, and education to research personnel regarding quality assurance audits. Clarify data discrepancies and deviations from standard operating procedures. Review and oversee adverse events, protocol deviations, and unanticipated problems to ensure appropriate and timely reporting. Analyze results and assist in the development of a preventive action plan for potential future discrepancies. Design and develop audit measures based on general SOPs and prepare checklists for inspections and compliance monitoring. Perform statistical analyses to identify data discrepancies and to determine error rates/trends. Develop, prepare, and present audit reports, as required.
Collaborate on the development and management of SOPs as well as other documentation according to all applicable regulations. Compile and maintain regulatory documentation databases or systems. Promote compliance through detection, resolution, and reporting of research activities that do not conform to federal, state, and local laws, as well as Institutional policies and procedures. Consult on policy interpretation related to research record privacy and appropriate access to electronic medical records. Remain apprised of changes in regulations and institutional policies that affect research and recommend changes to institutional procedures in response to changes in regulations or standards. Serve as a resource to the research community to answer questions regarding compliance issues that arise.
EDUCATION AND TRAINING (INTERMEDIATE)
Provide regulatory education and training to the research community to promote compliance with the HRPP/IRB policies and procedures. Develop, implement and document meaningful educational activities for the VUMC Research Enterprise in collaboration with team leaders. Assist with the development of customized educational sessions. Lead and coordinate ongoing training and support for investigators and research staff. Collaborate with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support. Create an environment that encourages and supports development and learning for research personnel through regular feedback.
Bachelor’s Degree (Required)
2 years’ experience (Required)
Advanced degree preferred
Minimum 2 years’ experience working in clinical drug trial/IND research
Strong project planning, strategy, leadership, negotiation and presentation skills as well as an ability to contribute creatively and practically to resolve problems and capitalize on opportunities.
Experience in developing an IND strategy and amendments
Ability to standardize consulting practices across multiple regions in order to streamline efficiencies and improve overall delivery of service while maintaining the highest standards in regulatory compliance.
Ability to establish and maintain relationships with sponsoring companies, investigators and institutional research units to optimize the performance of research activities while managing the activities of investigative sites across multiple protocols and multiple areas.
Bachelor's Degree (or equivalent experience) and 4 years relevant experience
Licensure, Certification, and/or Registration (LCR):
Additional Qualification Information:
- Certified IRB Professional Certification (CIP) required within the first year of employment in this position. Nursing license and/or CCRA, CCRC, CCRP or RAC certification preferred.
Physical Requirements/Strengths needed & Physical Demands:
- Sedentary category requiring exertion up to 10 lbs. of force occasionally and uses negligible amounts of force to move objects. Sedentary work involves sitting most of the time.
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: Carrying under 35 lbs: Transporting an object holding in hands, arms or shoulders, with help of coworkers or assistive device.
Occasional: Push/Pull: Exerting force to move objects away from or toward.
Occasional: Reaching above shoulders: Extending arms in any direction above shoulders.
Frequent: Reaching below shoulders: Extending arms in any direction below shoulders.
Frequent: Bimanual Dexterity: Requiring the use of both hands.
Continuous: Sitting: Remaining in seated position
Continuous: Fingering: Picking, pinching, gripping, working primarily with fingers requiring fine manipulation.
Continuous: Communication: Expressing or exchanging written/verbal/electronic information.
Continuous: Auditory: Perceiving the variances of sounds, tones and pitches and able to focus on single source of auditory information
Continuous: 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.
Continuous: Feeling: Ability to perceive size, shape, temperature, texture by touch with fingertips.
Req ID: 2103671
Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.
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