Clinical Research Regulatory Coordinator (Brandon, Florida)

Position Summary

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

Essential Responsibilities

• Study Start-Up and Site Activation
• Prepare and assemble study start-up regulatory packages.
• Coverage of essential documents required for study activation.
• Prepare sponsor-required regulatory submissions.
• Support feasibility, site qualification, site initiation, and activation activities.
• Coverage of sponsor and CRO requests during study start-up.
• Tracking of study activation milestones and regulatory deliverables.
• Maintenance of study start-up trackers and timelines.
• Institutional Review Board (IRB) Management
• Preparation and submission of initial IRB applications.
• Preparation and submission of IRB amendments, modifications, and protocol revisions.
• Preparation and submission of continuing reviews, annual renewals, and study status reports.
• Coverage of reportable events, protocol deviations, unanticipated problems, and safety notifications as required.
• Tracking of IRB approval periods and ensuring studies remain in compliance with approval requirements.
• Maintenance of IRB correspondence, approvals, and submission records.
• Communication of IRB approvals, determinations, and required actions to site staff.
• Ensuring appropriate implementation of approved informed consent forms and participant-facing documents.
• Maintenance of submission trackers and regulatory timelines.
• Serving as a liaison between research sites and central or local IRBs.
• Regulatory Quality Review
• Conducting centralized quality reviews of regulatory files across the research network.
• Reviewing regulatory binders and electronic regulatory files for completeness and compliance.
• Identification of missing, expired, or incomplete documentation.
• Performing regulatory reviews prior to study activation.
• Conducting periodic quality reviews of active studies.
• Reviewing studies prior to close-out and archival.
• Supporting audit readiness and inspection preparedness activities.
• Escalation of compliance concerns and quality issues to the Regulatory and Operations Manager.
• REALTIME eRegulatory Management
• Maintaining study regulatory files within REALTIME.
• Uploading, organizing, and managing regulatory documentation.
• Coverage of electronic signature routing and approval workflows.
• Maintaining document version control.
• Aiding sites with regulatory filing and document management activities.
• Aiding with the implementation of regulatory workflows within REALTIME.
• Aiding with user training related to REALTIME eRegulatory functions.
• Regulatory Maintenance
• Maintaining regulatory documentation throughout the study lifecycle.
• Tracking expiration dates for various essential documents.
• Coverage of collection and filing of updated regulatory documentation.
• Maintenance of delegation logs, training records, study-specific regulatory files, and essential documents.
• Ensuring regulatory files remain inspection-ready throughout study conduct.
• Sponsor and Site Support
• Serving as a regulatory resource for research sites.
• Responding to regulatory questions from site personnel.
• Aiding with sponsor portal document uploads and maintenance.
• Aiding with sponsor, CRO, and IRB communications.
• Coverage of regulatory documentation requests.
• Aiding with onboarding of new research sites and study teams.
• Study Close-Out and Archiving
• Conducting regulatory close-out reviews.
• Verification of completeness of essential documents prior to archival.
• Coordination of document retention and archiving activities.
• Training, SOPs, and Process Improvement
• Supporting implementation and maintenance of CVRS regulatory SOPs.
• Participation in regulatory training initiatives.
• Aid in standardization of regulatory processes across the network.
• Aid in CAPA and quality improvement activities as assigned.
• Contribution to the development of regulatory tools, templates, and best practices.

Qualifications

• Education
• Associate's Degree required.
• Bachelor's Degree in Life Sciences, Healthcare Administration, Public Health, or related field preferred.
• 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.
• Experience supporting remote research operations.
• 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 in a remote environment.
• Proficiency with Microsoft Office applications and electronic regulatory systems.