Clinical Research Regulatory Coordinator

Job Description

Job Description:

Insight Global is seeking a Clinical Research Regulatory Coordinator for a leading academic healthcare organization. This individual will be responsible for overseeing regulatory compliance across clinical research studies, including managing IRB submissions, maintaining regulatory binders and essential documentation, and supporting study startup through closeout. This role requires experience handling clinical trial documents such as protocols, ICFs, Investigator Brochures, FDA forms, and delegation logs, while managing multiple study timelines in a fast-paced, often multi-study or multi-site environment. The coordinator will work closely with investigators, research teams, sponsors, and CROs to ensure all regulatory requirements are met, support audits and inspections, and contribute to CAPA development and resolution. This position also plays a key role in training and supporting research staff, leveraging strong communication and technical writing skills to maintain compliance, accuracy, and audit readiness within a hospital or academic research setting.

Day to Day:

• Prepare, submit, and track IRB applications, amendments, continuing reviews, and reportable events

• Submit required documentation to external agencies (FDA, sponsors)

• Maintain accurate and complete regulatory binders (electronic and physical), including all essential documents

• Ensure proper version control of protocols, ICFs, Investigator Brochures, FDA Form 1572s, and DOA logs

• Confirm study activation only after all approvals are obtained

• Track staff certifications (CITI, GCP) and investigator credentialing

• Manage regulatory timelines across multiple studies and ensure deadlines are met, often supporting multi-study or multi-site environments

• Communicate timelines and status updates to investigators and coordinators

• Notify teams of IRB approvals and support re-consenting processes

• Coordinate with sponsors and CROs for document exchange and issue resolution using electronic regulatory systems when applicable

• Conduct internal quality reviews to ensure compliance with GCP, ICH, and HIPAA, maintaining strong attention to detail and documentation accuracy

• Support and participate in audits, inspections, and monitoring visits, including tracking findings and CAPA development and follow-up

• Maintain logs (IRB submissions, consent tracking, site visits, correspondence)

• Provide regulatory guidance, training, and onboarding support to research staff in a hospital or academic research setting

• Ensure proper document retention and filing per institutional and sponsor requirements

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Must-Haves:

• Bachelor’s degree required (Life Sciences, Public Health, Nursing, or related preferred)

• 3–5 years of clinical research regulatory compliance experience

• Experience with IRB submissions (initial, amendments, continuing reviews)

• Strong knowledge of FDA, ICH-GCP, HIPAA, and OHRP regulations Plusses:

• Master’s degree

• Certifications (CCRC, RAC, or NJ RN license)