Regulatory Affairs Coordinator

The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials.

• Ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site.
• Facilitates the study start‑up approval process and maintains documentation of regulatory compliance throughout the trial's duration for studies involving human subjects.
• Maintains accurate and up‑to‑date regulatory files and serves as a central regulatory resource for staff conducting clinical research.
• Prepares, reviews, and submits regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations.
• Reviews informed consents for institutional language and works with legal and sponsors to ensure CTA language is consistent with consent.
• Maintains accurate and up‑to‑date regulatory binders, including signed investigator agreements, CVs, and medical licenses.
• Develops and maintains electronic regulatory files in compliance with institutional and sponsor requirements.
• Tracks protocol approvals, renewals, and amendments to ensure study compliance.
• Monitors study compliance with federal regulations (FDA, OHRP) and guidelines (ICH, GCP).
• Maintains site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring proper documentation.
• Assists in preparing responses to audit findings and implementing corrective actions.
• Ensures prompt and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
• Provides study updates, deviations, and SAE reports to the Director of Research Services.

• Bachelor's degree required.
• Minimum of 2 years of experience in regulatory coordination within clinical research, preferably in oncology.
• Knowledge of FDA regulations, ICH guidelines, and GCP standards.
• Experience with IRB submissions, protocol amendments, and regulatory document management.
• Experience working with multiple central IRBs, understanding their submission process and requirements.
• Proficiency with electronic systems and Microsoft Office Suite.
• Strong organizational skills, attention to detail, and ability to manage multiple tasks efficiently.

• Seniority level:
  Associate
• Employment type:
  
  Contract
• Job function:
  Legal
• Industry: Pharmaceutical Manufacturing

Location:

Indianapolis, IN

Salary: $66,300.00 - $99,500.00