Regulatory Specialist, Office of Clinical Research

Working Title: Regulatory Specialist, Office of Clinical Research

Position Type: University Managerial and Professional Staff

Department: Cancer Center

Location: Charlottesville

Posting Date: 04-19-2017

Posting Summary:
The Cancer Center's Office of Clinical Research (CC OCR) at the University of Virginia is looking for a Regulatory Specialist.

The incumbent is responsible for submission of UVa Cancer Center protocols for regulatory review by Protocol Review Committee (PRC), IRB-HSR and FDA. This position assists OCR Clinical Trial Initiation Manager with essential clinical research constituencies (e.g. PIs, research coordinators, financial and administrative services, protocol and project managers, and legal counsel, as appropriate) to ensure the efficient and compliant initiation and regulatory management of clinical research protocols throughout the Cancer Center. The incumbent serves as the contact with relevant regulatory authorities (PRC, IRB, OHRP, FDA, etc.) and sponsor representatives. The incumbent is responsible for assigned projects, with optimal efficiency, through effective performance. The incumbent also assists the OCR Education/ Quality Assurance Specialist in training principal investigators and CRCs in the preparation of IRB applications.

To be considered for the position, candidates must have a Bachelor's degree, with at least two years of administrative, regulatory or research experience in a clinical research setting.

A Master's degree in biological, health science or a related field is preferred. Experience in regulatory management of clinical trials protocols, ideally cancer trials is preferred.

To apply, visit and search on Posting #0620780. Complete a Candidate Profile online; attach a curriculum vitae, cover letter, and contact information for three references.

Required Knowledge, Skills and Abilities:
1. Outstanding organizational skills.
2. Outstanding oral and written communication skills.
3. Exceptional attention to detail.
4. Knowledge of institutional, state and federal regulatory guidelines.
5. Knowledge of Good Clinical Practices (GCPs) and of the Code of Regulations.
6. Ability to learn quickly and work independently and efficiently with minimal supervision.
7. Ability to independently prioritize tasks and to work under deadline pressure.
8. Ability to interact effectively with a wide variety of individuals.
9. Strong computer skills.

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