Research Regulatory Coordinator

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

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.

The Research Regulatory Coordinator coordinates and maintains all regulatory documents, submissions, approvals, amendments, safety reporting, continuing reviews, and study close-out activities while supporting the successful execution of complex oncology clinical trials. The position required detailed oversight of protocol-specific regulatory requirements, safety and efficacy timepoints, and critical study milestones to ensure timely activation, ongoing compliance, and successful completion of research studies.

Serving as a key liaison between investigators, research teams, sponsors, Institutional Review Boards (IRBs), and regulatory agencies, the Research Regulatory Coordinator facilitates efficient communication, submission processes, and regulatory approvals across the site network. This role proactively manages study timelines, regulatory deliverables, and inspection readiness activities while maintaining the highest standards of data integrity, participant safety, and regulatory compliance.

ESSENTIAL FUNCTIONS:

• Establishes and maintains comprehensive regulatory files for assigned studies.
• Ensures all regulatory documentation 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.
• Coordinates and manages 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.
• Tracks and maintains 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.
• Supports 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.
• Coordinates the collection, review, and submission of local Serious Adverse Event (SAE) reports in collaboration with study coordinators, investigators, and data management personnel. Ensures proper documentation, regulatory filing, and timely reporting to IRBs and sponsors as required.
• Maintains documentation of protocol-specific training, investigator meetings, and study-related education for all study personnel. Ensures training records are current, complete, and available for regulatory review.
• Reviews and reports protocol deviations, violations, waivers, and non-compliance events to the IRB, sponsor, and other regulatory entities as required. Maintains supporting documentation and assists with corrective and preventive action planning when applicable.
• Communicates protocol updates, amendments, revised informed consent forms, safety notifications, and regulatory changes to investigators, study coordinators, and research staff. Ensures implementation of updated study requirements and maintains documentation of communication and training activities.
• Assists with preparation for internal quality reviews, sponsor audits, regulatory inspections, and accreditation visits. Participates in audit response activities, develops corrective and preventive action plans (CAPAs), tracks remediation efforts, and supports implementation of process improvements to maintain regulatory compliance.
• 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.
• Maintain professionalism in communication among cross-functional teams, fostering collaboration, accountability, and effective workflows across diverse stakeholders.   
• Uphold patient safety, confidentiality, and ethical standards. 
• Maintain required certifications (GCP, GDP, CITI) and remain informed on evolving oncology research practices and regulatory expectations. 

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 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.  

• Working knowledge of medical terminology, clinical workflows, and pharmaceutical research processes 

OOCUPATIONAL RISK CATEGORY:

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). 

• Must be able to effectively communicate in person, via phone, video conferencing, and email. 

• Rarely, domestic and/or international travel may be required for site visits, investigator meetings, or audits. 

• Occasional travel to nearby clinics may be required 

• Must have reliable home internet access to support remote work and virtual collaboration tools. 

• Occasional flexibility in work hours may be required to accommodate global team meetings or study timelines.