The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. 

The START Center for Cancer Research is seeking a Manager, Regulatory Operations who will lead and develop 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). 

This is a remote role. The annual base salary for this role is $105,000 - $135,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. 

Essential 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. 

Education & Experience

• 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.  

Physical and Travel Requirements:

• Travel required up to 10% of the time 
• Sitting for extended periods of time. 
• Typing and computer use for extended periods of time. 

Best-in-Class Benefits and Perks

We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:

• Comprehensive health coverage: Medical, dental, and vision insurance provided
• Robust retirement planning: 401(k) plan available with employer matching
• Financial security: Life and disability insurance for added protection
• Flexible financial options: Health savings and flexible spending accounts offered
• Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
• Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.

More about The START Center for Cancer Research

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com.

Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.