Job Summary: The Regulatory Specialist for the clinical trials office is responsible for all aspects involving regulatory requirements for studies and clinical trials.  The regulatory specialist will be responsible for submitting protocols and supporting documents to regulatory bodies, including the Medical Executive Committee and IRB. The incumbent will report directly to the Directors of CRHI.

Responsibilities:

• Submit continuations, amendments, generate reports, and maintain research files, including training and delegation logs consistent with the regulatory requirements for research studies/clinical trials, ensuring compliance with all federal and local agencies, including the FDA and local IRB. 
• Will attend team meetings, work with other staff to ensure all regulatory documents and requirements are met and up-to-date.
• Provide strategies for improving efficiency and quality.
• May represent investigators when meeting with pharmaceutical companies as needed.
• Other responsibilities as needed.

Qualifications/Requirements:

Experience: 2-3 years of research or regulatory experience in an academic research setting 

Education: Bachelors degree. Masters preferred. 

Licenses / Certifications:  N/A