Regulatory Spec Research
About The Position
Intercoastal Medical Group is seeking an experienced Regulatory Specialist in the research department. The Regulatory Specialist is responsible for managing the research regulatory files; communicating with the Clinical Research Coordinator Specialist, Research Manager and physicians; study start-up document preparation; IRB submissions; assisting with the regulatory aspect of monitoring visits; study close-out documentation; assisting CRC Specialists as needed. Intercoastal Medical Group is a professional association of more than 100 highly credentialed physicians encompassing many medical specialties. Intercoastal is committed to providing the highest quality care possible by offering superior healthcare to adults no matter their medical need. Intercoastal Medical Group is proud to offer conveniently located premier diagnostic and health care services in multiple locations in Sarasota and Manatee Counties, with highly experienced primary care and specialist physicians. In addition, our state-of-the-art ambulatory surgery center earns high praise from patients for its comfortable and comprehensive care.
Requirements
- Experienced Regulatory Specialist
- Managing research regulatory files
- Communicating with Clinical Research Coordinator Specialist, Research Manager and physicians
- Study start-up document preparation
- IRB submissions
- Assisting with the regulatory aspect of monitoring visits
- Study close-out documentation
- Assisting CRC Specialists as needed
Responsibilities
- Maintenance of all regulatory documentation for the site file
- Maintenance of up-to-date CVs, licenses, and training documentation for the physicians and research personnel
- Monitor temperatures of the study drug cabinet, research drug refrigerator, and research sample freezer, reporting excursions ASAP
- Travel to investigator meetings as necessary
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
