Senior Clinical Research Coordinator
Job location: Charlottesville, VA
Employment Type: Full-time
Posted data: 2019-04-11
Senior Clinical Research Coordinators, Non-Licensed, plan, organize, lead, and perform comprehensive advanced level clinical trial duties for multiple or complex clinical trials, focusing on the overall productivity and success of the clinical trials. They function under the Principal Investigator's medical license and cannot perform any tasks that by state or local law require a license to perform. They work independently and have the authority to adapt methods and procedures to meet the needs of the clinical trial. They influence the long term goals of clinical research trial and process. They often manage support teams. The impact of their decisions is wide in scope affecting both internal and external partners.
- Assist Principal Investigator in developing study protocols and submit the required documentation to the Institutional Review Board, the University, and the company or government sponsors. Submit study protocols and amendments, consent forms, and recruiting materials to the Coordinating center, IRB and department for approval within established guidelines.
- Conduct strategic planning and analysis of research portfolios, in conjunction with division management and Principal Investigators.
- Conduct research data analysis and assist state level teams as well as other study cores with data management/reporting.
- Compile data and documents during internal and external audits and is ultimately responsible for quality of submissions.
- Supervise 1 Research Communication Coordinator for the community collaboration and the associated work.
- Organize and manage the initial and continuing education training of the state-level community health workers and student assistants.
- Coordinating the efforts of the consultants with respect to community engagement and board training and management.
- Coordination of community level and participant board interactions and meetings nationally.
Education: Bachelor's degree
Experience: At least six years of clinical research experience. Related Master's degree may substitute for three years of experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA)required. Master's degree in related field with related work experience may substitute at the time of hire, with certification required within one year of certification eligibility.
- Advanced knowledge of University, state, and federal policies and regulations. Ability to conduct activities and make decisions according to ethical standards.
- Advanced knowledge of clinical research, human subjects research ethics, and IRB procedures. Demonstrate knowledge of a specific area of subject matter expertise. Proficient knowledge of medical terminology.
- Knowledge of community based engagement and/or community based participatory research collaboration.
- Demonstrate excellent oral and written communication in daily interactions. Proven ability to clearly articulate specific information in area of subject matter expertise. Proven ability to recruit and screen potential research participants.
- Proven ability to work independently and as part of a team. Work with senior leaders to accomplish goals. Ability to lead, train, and functionally supervise. Ability to mentor junior professionals.
** This position is contingent upon grant funding.The University of Virginia, including the UVA Health System and the University Physician’s Group are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.