Clinical Research Regulatory Coordinator

Job Description

Job Description Clinical Research Regulatory Coordinator Job Description

Position Summary (IN HOUSE position NOT REMOTE)

The Clinical Research Regulatory Coordinator provides centralized regulatory support for FLMR. Reporting to the Research Manager, this position supports regulatory start-up, site activation, IRB management, regulatory maintenance, and quality review activities across multiple clinical research sites.

The Clinical Research Regulatory Coordinator is responsible for preparing and maintaining regulatory documentation, coordinating IRB submissions and amendments, managing electronic regulatory files within REALTIME, supporting study activation activities, and conducting regulatory quality reviews. This position serves as a regulatory resource for research sites and helps ensure compliance with sponsor requirements, IRB requirements, Good Clinical Practice (GCP), FDA regulations, and FLMR Standard Operating Procedures.

The ideal candidate is highly organized, detail-oriented, experienced in clinical research regulations, comfortable working independently, and proficient in electronic regulatory systems.

Essential Responsibilities

Study Start-Up and Site Activation

• Prepare and assemble study start-up regulatory packages.
• Coordinate collection of essential documents required for study activation.
• Prepare sponsor-required regulatory submissions.
• Support feasibility, site qualification, site initiation, and activation activities.
• Coordinate sponsor and CRO requests during study start-up.
• Track study activation milestones and regulatory deliverables.
• Maintain study start-up trackers and timelines.

Institutional Review Board (IRB) Management

• Prepare and submit initial IRB applications.
• Prepare and submit IRB amendments, modifications, and protocol revisions.
• Prepare and submit continuing reviews, annual renewals, and study status reports.
• Coordinate submission of reportable events, protocol deviations, unanticipated problems, and safety notifications as required.
• Track IRB approval periods and ensure studies remain in compliance with approval requirements.
• Maintain IRB correspondence, approvals, and submission records.
• Communicate IRB approvals, determinations, and required actions to site staff.
• Ensure approved informed consent forms and participant-facing documents are appropriately implemented.
• Maintain submission trackers and regulatory timelines.
• Serve as a liaison between research sites and central or local IRBs.

Regulatory Quality Review

• Conduct centralized quality reviews of regulatory files across the research network.
• Review regulatory binders and electronic regulatory files for completeness and compliance.
• Identify missing, expired, or incomplete documentation.
• Perform regulatory reviews prior to study activation.
• Conduct periodic quality reviews of active studies.
• Review studies prior to close-out and archival.
• Support audit readiness and inspection preparedness activities.
• Escalate compliance concerns and quality issues to the Manager.

REALTIME eRegulatory Management

• Maintain study regulatory files within REALTIME.
• Upload, organize, and manage regulatory documentation.
• Coordinate electronic signature routing and approval workflows.
• Maintain document version control.
• Assist sites with regulatory filing and document management activities.
• Support implementation of regulatory workflows within REALTIME.
• Assist with user training related to REALTIME eRegulatory functions.

Regulatory Maintenance

• Maintain regulatory documentation throughout the study lifecycle.
• Track expiration dates for investigator licenses, CVs, GCP training, laboratory certifications, financial disclosures, and other essential documents.
• Coordinate collection and filing of updated regulatory documentation.
• Maintain delegation logs, training records, study-specific regulatory files, and essential documents.
• Ensure regulatory files remain inspection-ready throughout study conduct.

Sponsor and Site Support

• Serve as a regulatory resource for research sites.
• Respond to regulatory questions from site personnel.
• Support sponsor portal document uploads and maintenance.
• Assist with sponsor, CRO, and IRB communications.
• Coordinate regulatory documentation requests.
• Support onboarding of new research sites and study teams.

Study Close-Out and Archiving

• Conduct regulatory close-out reviews.