Clinical Research Regulatory Affairs Specialist RN PREFERRED **REMOTE AVAILABLE**
Vanderbilt University Medical Center
Remote or Nashville, TN
Clinical Research Regulatory Affairs Specialist RN PREFERRED **REMOTE AVAILABLE** - 2115243
**Job** : Research
**Primary Location** : TN-Nashville-2525 West End Ave
**Organization** : VICTR Vanderbilt Coord Center 104241
**Shift:** : First Shift
**Clinical Research Regulatory Affairs Specialist - VICTR - VCC**
The Clinical Research Specialist supports clinical research efforts by serving as the central resource to investigators to assist and provide regulatory guidance through experience with and knowledge of related local/state/ federal regulations. The Clinical Research Specialist closely and 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 for studies involving human subjects. This may include study planning, start-up and implementation, Investigational New Drug (IND) applications, drug development, regulatory and compliance issues, and budget development. Participates in training faculty and staff in the research community, as well as the development and revision of educational programs.
**About the Department:**
The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.org .
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**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.**
+ Navigates VUMC researchers through operationalizing study start-up, management, and closure.
+ Prepares, processes and manages all IRB submissions for initial and ongoing approval, adverse event reporting, continuing review and SMART IRB approvals.
+ Ensures compliance with Good Clinical Practice guidelines (GCP), internal procedures and appropriate regulatory agency guidelines
+ Provides training to site staff prior to implementation of new trials.
+ Collaborates and interfaces with Budget Analyst, Institutional Review Board (IRB), Office of Contract Management and Finance to secure adequate funding for Research Trials.
+ The responsibilities listed are a general overview of the position and additional duties may be assigned.
REGULATORY ACTIVITIES (INTERMEDIATE)
+ Utilize knowledge of local/state/federal regulations and institutional procedures to serve as a resource accurately and effectively on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, study design, marketing, and HRPP submissions.
+ Coordinate, prepare and review regulatory submissions/documents to the appropriate regulatory body.
+ 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)
+ 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.
+ May provide ongoing assistance, consultation, and education to research personnel regarding quality assurance audits. 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.
+ Serve as a resource to the research community to answer questions regarding compliance issues that arise.
SUBMISSION MANAGEMENT (INTERMEDIATE)
+ Reviews initial submissions to determine review category and action to be taken.
+ Manages new submissions and continuing review activities.
+ Completes submission applications, and other required documentation.
+ prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
+ Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.
+ Manages identified issues and provides feedback to leadership regarding resolution.
+ Review material for completeness, internal consistency with other documents, and conformance to applicable agency regulations; assures readiness for submission by gathering missing information, resolving internal consistency and regulatory issues; compiles high quality submissions that meet all applicable regulatory requirements.
EDUCATION AND TRAINING (INTERMEDIATE)
+ Provide regulatory education and training to the research community to promote compliance with the HRPP/IRB policies and procedures.
+ May 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, and lead and coordinate ongoing training and support for investigators and research staff, as needed.
+ Collaborate with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support, as required.
+ Create an environment that encourages and supports development and learning for research personnel through regular feedback.
Bachelor's or equivalent experience required (RN preferred)
3 years relevant experience working in clinical drug trial/IND research (Preferred)
**Physical Requirements/Strengths needed & Physical Demands:**
+ 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: Crawling:Moving about on hands and knees or hands and feet.
+ 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.
**Req ID:** 2115243
Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.