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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.
• Verify completeness of essential documents prior to archival.
• Ensure all required regulatory documentation has been collected and filed.
• Coordinate document retention and archiving activities.

Training, SOPs, and Process Improvement

• Support implementation and maintenance of CVRS regulatory SOPs.
• Participate in regulatory training initiatives.
• Assist with standardization of regulatory processes across the network.
• Support CAPA and quality improvement activities as assigned.
• Contribute to development of regulatory tools, templates, and best practices.

Qualifications

Education

• Associate's Degree required.

Experience

• Minimum 2 years of clinical research regulatory experience required.
• Experience preparing IRB submissions, amendments, and continuing reviews required.
• Experience supporting study start-up and site activation activities preferred.
• Experience working in a multi-study or multi-site environment preferred.

Preferred Qualifications

• Experience using REALTIME CTMS and eRegulatory modules strongly preferred.
• Experience with central IRBs and local IRBs.
• Experience supporting sponsor and CRO interactions.
• Experience preparing studies for sponsor monitoring visits, audits, and inspections.

Knowledge, Skills, and Abilities

• Strong knowledge of ICH-GCP guidelines.
• Working knowledge of FDA regulations and human subject protection requirements.
• Exceptional attention to detail and document accuracy.
• Strong organizational and project management skills.
• Ability to manage multiple studies and competing deadlines.
• Excellent written and verbal communication skills.
• Ability to work independently.
• Proficiency with Microsoft Office applications and electronic regulatory systems