Clinical Research QA & Education Coordinator
Working Title: Clinical Research QA & Education Coordinator
Position Type: University Managerial and Professional Staff
Department: Cancer Center
Posting Date: 04-13-2018
The University of Virginia Cancer Center's Office of Clinical Research (UVA CC OCR) seeks a Clinical Research Quality Assurance and Education Coordinator. This position is responsible for the Quality Assurance Plan for the UVA CC as well as training clinical research coordinators and other OCR staff.
As a QA Coordinator, this person is responsible for working with leadership to develop and implement the UVA Cancer Center's clinical research quality plan. The position is also responsible for ensuring that OCR staff understand the plan and the process for auditing studies ? both internally and by external entities.
As the Coordinator for affiliate sites conducting research under the UVACC Office of Clinical Research, this position is directly responsible for the oversight of trial conduct at affiliate sites according to the policies and procedures, good clinical practices and requirements of the UVA CC, UVA School of Medicine, FDA and NCI.
This position is restricted and contingent upon continuation of funding.
Qualified candidate must have a Bachelor's degree and a minimum of four years direct clinical research experience. An Associate's degree in Nursing with an RN licensure and four years of clinical research experience will substitute for the Bachelor's degree. Experience with cancer centers and oncology clinical trials programs is highly desired.
Required Knowledge, Skills and Abilities:
1. Extensive clinical trials management skills, including intimate knowledge of the process of clinical trials.
2. Possession of and ability to apply a broad knowledge of principles, practices and procedures in the specialized field of oncology research to complete complex assignments.
3. Outstanding organizational skills, as well as outstanding oral and written communication skills, and exceptional attention to detail.
4. Ability to maintain self-motivation.
5. Working knowledge of Good Clinical Practices (GCPs), as well as governmental and local regulations governing clinical research.
6. Strong knowledge of the Code of Regulations.
7. Abilkity to demonstrate typical analytical, comparative and evaluative skills when assessing various courses of action for training programs and review of staff compliance with institutional quality programs, including Data Safety Monitoring Committee (DSMC).
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