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 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. 

Essential 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. 

Education & Experience: 

• 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. 

Best-in-Class Benefits and Perks  

We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally:  

• 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  
• We’re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you’ll join a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.  

More About START  

START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – one of the most effective cancer drugs in medical history.  

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.