Lead, Regulatory Operations (Remote)

START Center for Cancer Research • Grand Rapids, MI

1d • $80,000 - $105,000 • 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 Lead, Regulatory Operations (Remote) who will serve as the regulatory subject-matter expert (SME) and provides guidance, training, and operational oversight to the Regulatory Operations team. This role oversees complex regulatory submissions, supports process improvement initiatives, delegates and prioritizes work as needed, performs quality reviews to ensure compliance and accuracy. The Lead will prepare and submit regulatory documents for new and ongoing clinical studies to the Institutional Review Board (IRB), US Food and Drug Administration (FDA), and Institutional Biosafety Committee (IBC). This role requires strong problem‑solving ability, sound judgment, and a high degree of independence. As team lead, ensure turnaround times are met, collect and review key metrics and continually improve processes to help achieve goals. This is a remote role. The annual base salary for this role is $80,000 - $105,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. A 10% annual performance bonus is offered as well.

Requirements

• Bachelor’s degree or equivalent experience.
• Minimum 5–7 years of regulatory experience in clinical research, including new study submissions
• Advanced knowledge of IRB, IBC, and FDA submission requirements.
• Proficiency with Microsoft Word and FileMaker Pro (or similar regulatory tracking systems).
• Exceptional organizational skills with attention to detail, accuracy, and completeness.
• Ability to independently manage multiple priorities, deadlines, and complex tasks.

Responsibilities

• Ensure turnaround times are met and actively seek ways to enhances processes to ensure departmental goals are consistently achieved.
• Prepare and submit new study applications and amendments to the IRB, including drafting and negotiating informed consent forms (ICFs) with Sponsors/CROs.
• Serve as the primary point of contact for assigned studies with the IRB, IBC, and FDA.
• Prepare and submit regulatory documents including revised protocols, investigator brochures, safety reports, deviations, clarifications, continuing review reports, and closure documents.
• Prepare and submit Expanded Access and other complex or high‑risk study submissions to the FDA.
• Track all submissions in FileMaker or applicable systems and maintain accurate status updates.
• Maintain complete, accurate, and audit‑ready Investigator Site Files (ISF), both paper and electronic.
• Lead and manage regulatory close‑out responsibilities for assigned studies.
• Train, mentor, and support Regulatory Operations team members, ensuring accurate submissions and proper regulatory filing.
• Perform quality control (QC) reviews of submissions and regulatory documents prepared by staff.
• Assist in work prioritization, workflow management, and cross‑functional coordination.
• Serve as the escalation point for complex regulatory questions or study challenges.
• Attend and represent Regulatory Operations in weekly Phase I meetings, Protocol Review, and Site Initiation Visits.
• Collaborate with other departments to resolve regulatory issues and ensure timely submission of deliverables.
• Develop, revise, and implement Work Instructions and SOPs.
• Assist with regulatory file preparation for audits and inspections; participate in CAPA development.
• Partner with leadership to improve regulatory processes, systems, and standardization across START USA sites.

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: Mid Level