Clinical Regulatory Specialist

About the role

The Clinical Regulatory Specialist will work under the direction of a Clinical Regulatory Manager or Director with the primary responsibility of assisting research sites with the conduct and compliance of Phase 2-4 pharma sponsored research studies. This position will be a collaborative individual contributor, working with internal stakeholders, clinical sites, and study sponsors/CROs – requiring results-driven administrative and regulatory work.

Responsibilities

• Working alongside research sites on essential regulatory document completion, ISF filing, and study correspondence
• Facilitating clinical trial regulatory activity from study start-up through closeout
• IRB submissions on behalf of sites
• Participating in monitor visits and site level audits
• May serve as a primary point of contact for clinical site staff

Requirements

• 2+ years of relevant work experience
• Previous experience as a clinical research coordinator or a site facing clinical regulatory dedicated research role
• Previous experience using a clinical trial management system (CTMS) is preferred

Pay

New York pay range: $72,000 USD - $83,000 USD