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Protocol Development Specialist

Charlottesville

Protocol Development Specialist

  • R0044081
  • Charlottesville, Virginia, United States
  • Protection, Compliance, and Regulation
  • The University of Virginia
The University of Virginia Cancer Center seeks a Protocol Development Specialist within the School of Medicine to support the Cancer Center’s Office of Clinical Research (CC OCR). The Office of Clinical Research within the Cancer center 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 Comprehensive 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. Hybrid work option preferred, remote work considered depending on experience and manager's discretion. Must be willing to travel to Charlottesville for training as needed.

Responsibilities:
  • 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.
  • Oversee and manage the development and implementation of clinical research projects.


Minimum Qualifications

Education : Bachelor's degree. 4 years of relevant experience may be considered in lieu of a degree.

Experience: At least two years of relevant experience.

Preferred Qualifications
  • E xcellent interpersonal and customer service skills, and organizational skills.
  • Ability to communicate effectively, both in writing and verbally.
  • Excellent skills with Microsoft Office, OnCore and Advarra-EDC experience.
  • 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.


Physical Demands
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs. Must be willing to travel to Charlottesville for training as needed.

Application Instructions: Please apply through Workday and complete an application online. Include the following documents:
  • A CV/resume
  • A cover letter is optional but strongly encouraged

All documents can be loaded into the resume submission field, multiple documents can be submitted into this one field. Internal applicants must apply through their UVA Workday profile. Incomplete applications will not be considered.

This position will remain open until filled. This is an Exempt level, benefited position. This position is a restricted position and is dependent upon project need, availability of funding and performance in the role. Hybrid work option preferred, remote work considered depending on experience and manager's discretion. Must be willing to travel to Charlottesville for training as needed.

For questions about the application process, please contact Margaret Weeks , Academic Recruiter. Before a formal offer of employment is extended, the selected candidate will undergo a background check per university policy.

COVID Vaccination Requirement and Guidelines

Please visitthe UVA COVID-19 Job Requirements and Guidelines webpageprior to applying for current information regarding vaccination requirementsandguidelines for employment at UVA.

The University of Virginia, i ncluding 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.

 

Each agency within the Commonwealth of Virginia is dedicated to recruiting, supporting, and maintaining a competent and diverse work force. Equal Opportunity Employer

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