In collaboration with the VUMC Human Research Protections Program (HRPP), the Research Services Consultant I (RSC I) assists with the optimal application of the Federal, State, and local laws, guidance documents, VUMC Institutional policies, and Human Research Protection Program (HRPP) policies and procedures while meeting the objectives of the VUMC research community. Consults on research and regulatory issues in collaboration with the team(s) to identify solutions and develop improvement processes. The RSC I researches topics of departmental, institutional or strategic importance.
- Assists researchers and clinicians in improving the quality of research and grants by identifying collaborators, connecting investigators with resources/funding opportunities, and developing tools to further the research enterprise.
- Serves as a central resource for the research community to provide expertise and guidance on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
- Participates in institutional activities regarding culture and regulatory issues related to research.
- Collaborates with internal and external customers to develop and evaluate services for the improvement of human research protection programs.
- Builds and maintains effective working relationships with key study personnel, clinical resources and regulatory colleagues throughout VUMC.
- Collaborates with PIs and other members of the research teams in the development of study plans and protocols and contributes to the ongoing analysis and modification of protocols as appropriate.
- Guides Investigators and key study personnel in the development of protocols and study budgets to capture all sturdy costs and compliance with regulations, and assure adherence to FDA and other regulatory guidelines.
- Responsible for the comprehension, management, and facilitation of HRPP regulatory assurance(s), contracts, agreements, and HRPP policies and procedures.
- Provides training and guidance to lower level personnel involved in study planning, implementation and evaluation.
- Responsible for developing, implementing, and maintaining a comprehensive/strategic Continuous Quality Improvement (CQI) program for research programs within the Research Enterprise.
- Educate the campus community regarding resources available to clinicians and researchers to improve all aspects of the research enterprise.
- Assists in the preparation of protocol submissions, amendments, modifications and reports required by the HRPP and study sponsors.
- Organizes administrative teams to support national in person meetings (e.g., set meeting agendas, invites speakers, engages possible attendees, advertises events, books meeting locations, books audio-visual services, and provides scientific/technical consultation).
- Supervises the creation of all materials and computer-based systems to be used for documentation purposes.
- Conducts internal and external audits of research at periodic intervals to identify and analyze data errors, data discrepancies, process errors, and deviations from study protocols to assure compliance with applicable regulatory requirements and standard operating procedures.
- Works in concert with Vanderbilt leadership in developing infrastructure for improving expanded access to investigational therapies for seriously ill patients.
- Collaborates with leadership and other colleagues in development and submission of grant proposals related to key national initiatives.
- Provides research support services to Vanderbilt colleagues, including evidence reviews and other project work.
- Excellent organizational and time management skills
- Excellent oral and written communication skills
- Analytical and problem-solving skills
- Ability to multi-task
- Excellent self-initiative and motivation
- Excellent teamwork and facilitation skills
- Excellent customer service skills
- Computer proficiency
Please complete your application and submit your resume to https://vanderbilt.taleo.net/careersection/.vu_cs/jobdetail.ftl?job=1604285.