Working Title: Regulatory Specialist
Position Type: University Managerial and Professional Staff
Department: Center for Diabetes Technology
Posting Date: 01-26-2018
The Center for Diabetes Technology (CDT) at the University of Virginia is seeking a Regulatory Specialist to support research at the Fontaine Research Park. The incumbent completes and maintains regulatory documents for clinical studies/trials to ensure protocol, regulatory and Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) compliance and assists the Regulatory Manager. The position requires strong written communication skills, attention to detail, ability to meet multiple and changing deadlines, the ability to interact with a variety of people and to consult numerous sources for information in order to prepare documents and assist with responses to FDA, IRB and sponsor questions that are compatible with numerous policies and procedures. Incumbent must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately and quickly.
This position requires a Bachelor's degree and a minimum of four years of relevant clinical experience. An advanced degree may substitute for two years of experience.
The Clinical Research Coordinator (CCRC) and/or Clinical
Research Associate (CCRA) or similar certification is required within one year from date of hire.
This position is restricted and is contingent upon availability of funding.
Required Knowledge, Skills and Abilities:
1. Must be able to maintain confidentiality.
2. Strong multi-tasking skills.
3. Demonstrated organizational skills including ability to develop accurate filing systems.
4. Ability to interact with various levels of staff with confidence at all times.
5. Ability to work independently with minimal supervision.
6. Experience with Microsoft Office products such as: Word and Excel.
7. Strong written communication skills and attention to detail.
8. Ability to meet multiple and changing deadlines.
9. Must be able to work in a very busy interactive environment with frequent interruptions and to perform tasks accurately and quickly.
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