Protocol Development Specialist
Job location: Charlottesville, VA
Employment Type: Full-time
Posted data: 2021-03-30
The Cancer Center Office of Clinical Research (OCR) at the University of Virginia is seeking a Protocol Development Specialist. The Cancer Center OCR provides centralized support for the conduct of clinical trials to all Cancer Center Investigators. The Protocol Development Specialist is responsible for the development and implementation of investigator-initiated clinical trial protocols and for providing regulatory oversight for clinical trials for investigators in the UVA Cancer Center. The incumbent works with University faculty and staff, local and federal oversight agencies and industry and/or government funding agencies to ensure accurate progress of clinical trials from the planning stage through study completion.
- Write and edit clinical trial protocols and protocol related documentation (e.g. consent forms, regulatory documents, study synopses)
- Analyze study protocols to understand workflow and protocol requirements
- Develop study budgets
- Prepare and submit required protocol and regulatory documentation for internal and external reviews (e.g. PRC, IRB, FDA)
- Create and maintain regulatory files for clinical trials
- Make decisions about routine matters, prioritize daily tasks and projects, and develop short-term and long-term timelines for project completion
- Bachelor's degree with two years of relevant experience is required. Four years of relevant experience is preferred.
- Must have excellent interpersonal and customer service skills, and organizational skills.
- Ability to communicate effectively, both in writing and verbally is required.
- Excellent skills with Microsoft Office is required, OnCore experience is preferred.
- Prefer experience in development of clinical trials protocols, ideally cancer trials.
- Proficient knowledge of medical terminology.
- Knowledge of human subjects research ethics.
- Knowledge of IRB procedures and submission process along with the federal regulations of working with human subjects.
- Working knowledge of research methodologies.
- Exceptional attention to detail. Knowledge of institutional, state and federal regulatory guidelines.
- Knowledge of Good Clinical Practices (GCPs) and of the Code of Regulations.
Anticipated Hiring Range: Salary commensurate with qualifications and experience, with UVA benefits.
Please apply through Workday, and search for “Protocol Development Specialist". Complete an application online and attach a cover letter and a CV/resume all into the resume submission field, multiple documents can be submitted into this one field. Internal applicants must apply through their UVA Workday profile.
For questions about the application process please contact Bethany Case, Recruiter.
This position is restricted and contingent upon the continuation of funding, project need, and satisfactory performance. This is an exempt level, benefited position. The University will perform background checks on all new hires prior to employment. This position cannot offer sponsorship.
The University of Virginia, including the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician’s Group and the Claude Moore Health Sciences Library, 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 or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.