Remote Regulatory Operations Lead – Oncology

The START Center for Cancer Research; United States; À distance; USD 80 000 - 105 000; Plein temps

Avantages offerts par ce poste

Health coverage

401(k) plan with employer matching

Life and disability insurance

Health savings and flexible spending

Paid time off and flexible schedule

Résumé du poste

The START Center for Cancer Research seeks a Lead, Regulatory Operations (Remote) to guide the Regulatory Operations team, oversee complex submissions to IRB, FDA, and IBC, and drive process improvements. The role requires strong problem-solving, judgment, and independence.

As team lead, you will ensure timely submissions, train staff, review quality, and collaborate with cross-functional groups across START USA sites while supporting policy development and SOPs.

Qualifications

• Bachelor’s degree or equivalent experience required.
• Minimum 5–7 years of regulatory experience in clinical research, including new study submissions.
• Leading, training, onboarding direct reports with previous supervisory experience.
• 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.

Responsabilités

• Ensure turn around 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.

Connaissances

Regulatory operations

Leadership

IRB submissions

FDA submissions

Formation

Bachelor’s degree or equivalent experience

Outils

FileMaker Pro

Microsoft Word

Description du poste

The START Center for Cancer Research seeks a Lead, Regulatory Operations (Remote) to guide the Regulatory Operations team, oversee complex submissions to IRB, FDA, and IBC, and drive process improvements. The role requires strong problem-solving, judgment, and independence.

As team lead, you will ensure timely submissions, train staff, review quality, and collaborate with cross-functional groups across START USA sites while supporting policy development and SOPs.