Manager, Regulatory Operations (Remote)

More About START • Grand Rapids, MI

7d • Remote

About The Position

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe. We are seeking a Manager, Regulatory Operations (Remote). This role performs operational leadership for the Regulatory Operations function across START USA. This role leads and develops a team that includes Specialists), and Assistants to ensure timely, accurate, and compliant regulatory submissions and maintenance of inspection-ready Investigator Site Files (ISFs). The Manager, Regulatory Operations is accountable for team performance, process standardization, metrics, training and onboarding, and continuous improvement of systems and workflows supporting IRB, IBC, and FDA interactions, in alignment with applicable regulations and guidelines (e.g., GCP, FDA BIMO, 21 CFR Part 11).

Requirements

• Bachelor’s degree or equivalent experience in lieu of degree.
• 5+ years of progressive experience in a regulatory research setting, including oversight of new study submissions and ongoing maintenance and management experience.
• Proficiency with Microsoft Office and Regulatory Data Tracking / Document Management Systems (e.g., Jira, Veeva, Advarra E-Reg).
• Excellent leadership, organizational, and communication skills with a high level of attention to detail.
• Advanced working knowledge of IRB, FDA, and IBC requirements with experience supporting audit / inspection readiness.

Responsibilities

• Provide direct people leadership for assigned team.
• Partner with the Regulatory Operations Leadership and Quality Assurance to set departmental goals and ensure timely execution of regulatory deliverables that support study startup, conduct, maintenance and close out.
• Oversee day to day regulatory operations to ensure submissions are accurate, complete and on time; balance workloads and assign / re-distribute studies based on capacity and complexity.
• Establish, maintain, and continuously improve SOPs, work instructions, templates, and training materials to drive standardization, quality, and scalability across sites.
• Maintain relationships with Institutional Review Board(s) (IRB) used and Sponsors/CROs.
• Supervise day-to-day activities of the Regulatory Operations staff to ensure that submissions are accurate, and deadlines are met.
• Monitor key metrics (e.g., turnaround times, aging, quality findings) and drive corrective actions and process improvements in partnership with Quality Assurance and cross-functional stakeholders.
• Serve as an escalation point for complex regulatory issues and facilitate timely resolution with IRBs, IBCs, FDA, Sponsors/CROs, and other departments.
• Attend SOP Committee Meetings quarterly, provide regulatory and data input, and revise any SOPs as needed per the meetings.
• Collaborate with other START departments, including Site Clinical departments and Shared Services departments, and Regional Director to provide support and leadership to effectively meet deadlines, prepare for audits, manage various electronic systems and START templates in use at START (i.e., FileMaker, CITI portal, study portals, e-signature platforms, etc.), and special projects as needed.
• Prepare and submit new studies, including drafting the informed consent (IC), to the IRB (local and hospital) as assigned.
• Serve as the main point of contact with the Sponsor/CRO in negotiating the IC for IRB submission.
• Serve as the main point of contact with the IRB(s) for the studies.
• Enter submission dates in FileMaker database, note pending information, and generate status reports as required.
• Respond to inquiries and follow up on pending items.
• Prepare and submit study documents to the IRB (local and hospital) for assigned studies. This includes, but is not limited to, revised protocols, revised investigator’s brochures, protocol clarification letters/memos, revised ICs, new ICs, continuing review reports, closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, and waivers.
• Serve as the main point of contact with the IRB(s) for the studies.
• Enter submission dates in FileMaker database, note pending information, and generate status reports as required.
• Respond to inquiries and follow up on pending items.
• Prepare and submit study documents to the Institutional Biosafety Committee (IBC) as assigned.
• Serve as the main point of contact with the IBC for the studies.
• Enter submission dates in FileMaker database, note pending information, and generate status reports as required.
• Respond to inquiries and follow up, as required, on pending items.
• Prepare and submit Expanded Access Studies to the US Food and Drug Administration (FDA) as assigned.
• Serve as the main point of contact with the FDA and IRB for the studies.
• Enter submission dates in FileMaker database, note pending information, and generate status reports as required.
• Respond to inquiries and follow up, as required, on pending items.
• Maintain the ISF (paper and/or electronic) for assigned studies. This includes, but is not limited to, IRB submissions, IRB approvals, study documents, and study correspondence.
• Prepare and manage Close-Out Visits for assigned studies.

Benefits

• 401(k) retirement savings plan with employer match
• Eligibility for an annual performance bonus, based on role and company results
• Generous paid time off and paid holidays
• Comprehensive medical, dental, and vision coverage and optional insurance options
• Company paid life and disability insurance for added financial protection
• Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one
• Flexible FSA and HSA plans to support your financial wellness
• Commitment to a supportive environment that values balance, wellbeing, and flexibility

What This Job Offers

• Job Type: Full-time
• Career Level: Manager