REGULATORY AFFAIRS SPEC
Duties: The Regulatory Specialist will provide regulatory support and expertise associated with clinical trials within the Penn Department of Medicine's newly created Clinical Trials Unit. The person will support a diverse group of investigators and coordinators, involving work on a wide spectrum of clinical trials ranging from phase I-IV, investigator/industry-initiated, different disease states and varying complexities. Involvement will range from consulting to serving as the primary regulatory contact for a study handling all regulatory submissions, regulatory binders, monitor visits, and compliance checks. The Regulatory Specialist will play a key role in study start-up and be involved in study intake & feasibility.
Position is contingent on continued funding.
Qualifications: A Bachelor's Degree and 3 years to 5 years of experience, or equivalent combination of education and experience, are required. Five to 7 years of experience preferred.
Reference Number: 40-26451
Salary Grade: 027
Employment Type: Exempt
Org: DM-Department of Medicine
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: A-General/Professional Administrative