Research Regulatory Coordinator

Job Description

The Research Regulatory Coordinator serves as the regulatory specialist for a network of oncology-focused clinical research sites, providing comprehensive regulatory oversight for clinical trials from study start-up through close-out. This role is responsible for managing regulatory activities across multiple oncology protocols and phases of research, ensuring compliance with applicable federal, state, sponsor, IRB, and institutional requirements.

Essential Functions

• Establishes and maintains comprehensive regulatory files for assigned studies.

• Safeguards all regulatory documentation, ensuring it is organized, complete, inspection-ready, and maintained in accordance with sponsor, institutional, and regulatory requirements.

• Prepares and submits initial regulatory documentation packages to sponsors and CROs, including FDA Form 1572, investigator CVs, medical licenses, financial disclosures, training records, and other required site qualification documents to support study activation.

• Reviews, distributes, tracks, and obtains required signatures on study protocols, protocol amendments, Investigator’s Brochures, informed consent forms, and other essential regulatory documents within established timelines.

• Completes, collects, reviews, and maintains Financial Disclosure Forms for investigators and applicable study personnel throughout the duration of assigned studies, ensuring timely updates and sponsor reporting requirements are met.

• Creates, updates, and maintains Delegation of Authority Logs, FDA Form 1572s, Site Signature Logs, and other study-specific regulatory records to ensure accurate documentation of study personnel roles, responsibilities, and qualifications.

• Captures, reviews, and submits Institutional Review Board (IRB) submissions for initial study approval, amendments, continuing reviews, reportable events, protocol deviations, consent revisions, study closures, and all other required regulatory communications.

• Ensures all submissions are complete, accurate, and submitted within required timelines, tracking and maintaining critical IRB and regulatory deadlines, including approval expirations, continuing review requirements, investigator credential renewals, training expirations, and study-specific reporting obligations to ensure uninterrupted study compliance.

• Reviews, processes, and files IND Safety Reports, SUSARs, investigator notifications, safety letters, and other interim safety communications. Assesses reporting requirements and ensures timely submission to IRBs and applicable oversight bodies in accordance with regulatory requirements and organizational SOPs.

• Coordinates sponsor, CRO, and monitoring visits by maintaining audit-ready regulatory files, preparing requested documentation, resolving regulatory queries, and serving as a resource for regulatory-related questions and follow-up activities.

• Collaborates with investigators, study coordinators, sponsors, CROs, IRBs, and institutional departments to facilitate study activation, ongoing compliance, and successful study close-out activities across a portfolio of oncology clinical trials.

• Maintains knowledge of current FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional policies governing clinical research and applies regulatory expertise to support compliant study conduct throughout the clinical trial lifecycle.

Knowledge, Skills & Abilities

• Education & Experience: Bachelor’s Degree in a health, life science, or related field required; in lieu of a degree, a minimum of 6 years of experience in clinical research, healthcare administration or a regulatory related field is required. Minimum of 2+ years of experience in clinical research required; OR 1 year of clinical research experience plus 1 year of healthcare administration or regulatory experience required. Clinical research regulatory experience is preferred. Good Clinical Practice (GCP) certification required within 30 days of hire if not already available. This certification will be provided by the institution.

• Knowledge: Knowledge of GCP, ICH guidelines, FDA regulations, and institutional policies governing human subject research. Strong analytical and critical thinking skills, with the ability to interpret data and resolve discrepancies with a high degree of accuracy. Excellent organizational, communication, and time-management skills, the ability to prioritize multiple competing deadlines and priorities in a fast-paced environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SharePoint and OneNote.

• Physical Requirements: Prolonged periods of working on a computer in both home and office settings. Ability to sit, stand, and move within an office environment for extended periods. Manual dexterity to operate a laptop, keyboard, mouse, and standard office equipment. Ability to occasionally lift or move items up to 20 pounds (e.g., study materials, regulatory binders, laptop).