Senior Regulatory Compliance Coordinator

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Compliance Coordinator based in the United States.

This is a senior clinical research operations role supporting the regulatory management of cancer clinical trials from initial development through study closure.
You will work closely with investigators, research teams, and clinical trial office stakeholders to ensure studies meet regulatory and compliance requirements.
The role covers protocol development, submission coordination, regulatory documentation, safety reporting, and ongoing study oversight.
You will serve as a key resource for investigators and research teams, helping ensure regulatory integrity across assigned studies.
The position also provides an opportunity to mentor junior staff and strengthen the quality and consistency of regulatory processes across multiple study teams.
You will work across a diverse portfolio that may include industry-sponsored, consortium, NCI, and investigator-initiated trials.
Success in this role requires strong organization, regulatory knowledge, communication skills, and the ability to collaborate effectively in a complex clinical research environment.

Accountabilities:

• Manage the regulatory components of assigned cancer clinical trials throughout the submission and study lifecycle, from initial approval through study closure.
• Ensure the regulatory integrity, completeness, and accuracy of assigned clinical trial documentation and submissions.
• Work closely with investigators and research teams to develop new clinical trials and support protocols during the development and start-up phases.
• Serve as a primary regulatory contact during protocol development, coordinating communications and documentation with reviewing committees and relevant personnel.
• Coordinate and prepare materials required for Institutional Review Board (IRB) submissions and reviews.
• Support the preparation and submission of regulatory and safety documentation to sponsors, regulatory bodies, and other applicable agencies.
• Correspond with reviewing committees and other stakeholders to facilitate timely regulatory approvals, responses, amendments, and ongoing study requirements.
• Assist with clinical trial budget development by identifying research-related non-billable activities and requirements.
• Coordinate start-up meetings for new protocols and ensure relevant study teams have the information and documentation required to initiate trials.
• Provide guidance and serve as a regulatory resource for investigators, research coordinators, and other study team members.
• Mentor junior regulatory staff and provide oversight and training to study teams responsible for preparing and submitting regulatory documentation.
• Promote consistent regulatory practices and support continuous improvement across clinical research operations.
• Collaborate closely with investigators, research administration, clinical trial teams, and other stakeholders to resolve regulatory issues and maintain study progress.
• Support a diverse portfolio of cancer clinical trials, including industry-sponsored, consortium, NCI, and investigator-initiated studies.

Requirements:

• Demonstrated experience in clinical research, regulatory affairs, clinical trial coordination, or a closely related field.
• Strong understanding of the regulatory requirements and processes associated with clinical research and cancer clinical trials.
• Experience preparing, reviewing, and submitting documentation for IRB review and other regulatory or safety reporting requirements.
• Ability to manage clinical studies through regulatory submission, approval, maintenance, amendment, and closure activities.
• Experience working with investigators and multidisciplinary research teams in a clinical or academic research environment.
• Strong organizational and project coordination skills, with the ability to manage multiple studies, deadlines, submissions, and priorities simultaneously.
• Excellent written and verbal communication skills, with the ability to correspond effectively with investigators, committees, sponsors, agencies, and research personnel.
• Strong attention to detail and commitment to maintaining accurate, complete, and compliant regulatory documentation.
• Ability to identify regulatory requirements, anticipate potential issues, and proactively support timely resolution.
• Demonstrated ability to mentor, train, and provide guidance to junior staff and study teams.
• Collaborative mindset and ability to work effectively with both research and administrative stakeholders.
• Comfortable working in a team-oriented environment while independently managing assigned responsibilities.
• Experience with industry-sponsored, consortium, NCI, or investigator-initiated clinical trials is highly desirable.

Benefits:

• Opportunity to contribute to the successful management of cancer clinical trials and clinical research initiatives.
• Senior-level role with responsibility for regulatory oversight, study start-up, compliance, and staff mentorship.
• Collaboration with investigators, research professionals, clinical trial teams, and administrative stakeholders.
• Exposure to a diverse portfolio of industry-sponsored, consortium, NCI, and investigator-initiated studies.
• Opportunity to develop and strengthen expertise in clinical trial regulatory operations and compliance.
• Professional growth through mentoring responsibilities and cross-functional collaboration.
• Team-oriented clinical research environment focused on regulatory integrity, quality, and patient-focused research.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1