Job Description

We’re seeking a detail-oriented and experienced Regulatory Coordinator to manage and support regulatory compliance across multiple clinical trial sites. This role is essential to the success of our ongoing studies and will involve working closely with internal teams, sponsors/CROs, and regulatory agencies to ensure adherence to all applicable protocols. This position will involve travel between our locations and satellite sites within the company as needed for regulatory support.

Key Responsibilities:

• Prepare, submit, and maintain regulatory documents for IRB and sponsor submissions across multiple studies
• Ensure all study documentation complies with GCP, FDA regulations, and institutional policies
• Maintain regulatory binders and essential study documentation across all active and archived studies
• Track protocol amendments, safety reports, and correspondence with regulatory bodies
• Coordinate and support site initiation visits, monitoring visits, audits, and inspections from a regulatory perspective
• Work collaboratively with clinical and operations staff to ensure timely startup and regulatory readiness
• Assist in developing SOPs and regulatory workflows to support regulatory operations
• Provide on-site regulatory support for trial sites during SIVs, monitoring visits, and other ad hoc visits as needed

Qualifications:

• Bachelor's degree preferred
• 4+ years of experience in clinical research regulatory coordination
• Deep understanding of FDA regulations, GCP, and IRB processes
• Background in therapeutic areas such as ophthalmology, dermatology, or pulmonology is preferred
• Experience completing internal/external audits
• Strong organizational skills and attention to detail
• Ability to manage multiple studies and deadlines simultaneously
• Excellent written and verbal communication skills
• Proficient in Microsoft Office and electronic regulatory systems
• Willingness and ability to travel (up to 25%) across sites
• Experience supporting multi-site or decentralized clinical trials
• Spanish fluency is a plus
• Familiarity with clinical trial management systems (CTMS) and electronic regulatory platforms
• A proactive mindset and collaborative spirit are key to success in this role

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