Regulatory Coordinator

Regulatory Coordinator, Clinical Research

Position Summary
The Regulatory Coordinator is responsible for managing and executing the regulatory
compliance activities of clinical research studies. This role ensures that all clinical trials are
conducted in accordance with Good Clinical Practice (GCP) guidelines, federal and sponsor
regulations, and institutional policies and procedures. The Regulatory Coordinator works closely
with the Principal Investigator (PI) and the research team to ensure all regulatory documents
are accurate, complete, and maintained in an audit-ready state throughout the entire lifecycle
of the trial, from study startup to close-out.

Roles and Responsibilities

• Regulatory Submissions and Maintenance:
  • Prepare, manage, and submit all required Institutional Review Board (IRB) and other regulatory submissions, including initial protocols, amendments, continuing reviews, safety reports, and close-out documentation.
  • Maintain all regulatory files in both paper and electronic formats, ensuring they are continuously updated and prepared for audits.
  • Serve as the primary liaison between the research team, sponsors, and the IRB for all regulatory matters.
  • Ensure timely renewals, amendments, and reporting of adverse events and protocol deviations.
  • Perform other duties assigned to support overall regulatory functions and department.
  • Maintain investigator qualification documentation, including CVs, medical licenses, DEA registrations, financial disclosure forms, and training records, ensuring all documentation remains current and compliant.
  • Track regulatory milestones, approval expirations, and submission deadlines to ensure timely completion of all study-related regulatory activities.
  • Perform routine quality control reviews of regulatory files to ensure completeness, accuracy, and inspection readiness.
• Compliance and Quality Control:
  • Ensure all clinical trial activities adhere to federal regulations (e.g., FDA), sponsor requirements, and ethical guidelines for human subjects research.
  • Assist in the preparation for internal and external audits and address any compliance-related findings in a timely manner.
  • Assist in developing and implementing guidance and training for clinical research and regulatory processes.
  • Monitor and stay current with updated industry guidance and regulations.
  • Conduct periodic reviews of regulatory documentation to verify compliance with protocol requirements, sponsor expectations, Good Clinical Practice (GCP), and applicable regulations.
  • Assist with protocol deviation documentation, reporting, and follow-up activities as required by sponsors, IRBs, and organizational policies.
  • Support corrective and preventive action (CAPA) activities related to audit findings, compliance concerns, and process improvement initiatives.
  • Maintain all regulatory records in an audit-ready state and support sponsor, CRO, FDA, and internal audits and inspections.
• Study Coordination:
  • Facilitate the regulatory aspects of study initiation, including site activation and contract review.
  • Coordinate with clinical operations to ensure regulatory readiness for enrollment.
  • Collaborate with the PI and research staff to complete all required regulatory documents (e.g., delegation of authority logs, conflict-of-interest forms).
  • Prepare and finalize informed consent forms, ensuring they comply with institutional and sponsor requirements.
  • Provide timely and accurate updates to the research team regarding protocol amendments, enrollment closures, and study close-outs.
  • Maintain accurate tracking of all regulatory documents and approvals.
  • Maintain and track study-specific training documentation, ensuring research personnel complete required protocol, GCP, safety, and sponsor-required training.
  • Assist in maintaining essential study documents and investigator site files (ISFs) throughout the lifecycle of the study.
  • Collaborate with cross-functional teams to support study startup, enrollment readiness, amendment implementation, and study close-out activities.
  • Generate and maintain regulatory tracking logs and reports to support study oversight and compliance activities.

Qualifications

• Education and Experience:
  • A bachelor's degree in a life science, healthcare administration, public health, or a related field is preferred.
  • Prior experience in clinical research, regulatory affairs, or a related healthcare industry is preferred.
  • Experience with IRB submissions, regulatory document management, study startup activities, and clinical trial compliance is strongly preferred.
  • Knowledge of Good Clinical Practice (GCP) and human research protections is essential.
• Skills:
  • Strong knowledge of federal and state regulations governing clinical trials.
  • Excellent written and verbal communication skills to effectively communicate with staff, sponsors, and regulatory agencies.
  • Exceptional attention to detail and organizational skills to manage and maintain large volumes of complex documents.
  • Ability to work independently, manage multiple tasks with competing deadlines, and problem-solve effectively.
  • Proficiency with Microsoft Office Suite (Word, Excel, Outlook) and experience with electronic regulatory systems (eReg), CTMS platforms, IRB portals, and document management systems is preferred.
  • Working knowledge of ICH-GCP guidelines, FDA regulations, HIPAA requirements, and human subject protection principles.
  • Ability to interpret clinical research protocols and regulatory requirements.
  • Strong project management skills with the ability to manage multiple studies and competing deadlines.
  • Demonstrated commitment to quality improvement, compliance, and process standardization.

Preferred Qualifications

• Individuals who are available to travel between local sites are preferred.

Pay

• $24-30/hr