Clinical Research Team Lead, Regulatory
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Job Description
Clinical research regulatory lead overseeing oncology trial compliance at University of Cincinnati Cancer Center. Guiding regulatory teams, protocol activation, IRB coordination, and CTMS documentation.
Responsibilities:
- Guide and direct day-to-day functions of regulatory clinical research professionals supporting disease teams within the Clinical Trials Office
- Provide support, direction, and coaching in training, problem resolution, planning, and work assignment delegation
- Serve as a subject matter expert for research regulatory activities, procedures, and Good Clinical Practice adherence
- Provide input for performance evaluations and serve as a contact for scheduling needs
- Provide coverage for direct reports or lower-level staff as needed
- Contribute to developing processes, procedures, tools, and training to enhance clinical research activities
- Guide team members in managing non-compliant data collection or study activities and resolving future compliance issues
- Track research study progress and develop team work-prioritization plans
- Work with study sponsors, IRB, and other regulatory offices
- Ensure protocols move through the regulatory process toward activation for participant accrual in accordance with institutional and National Cancer Institute requirements
- Work collaboratively in a fast-paced, customer-focused environment
- Oversee adherence to SOPs, Good Clinical Practice, and FDA regulations
- Ensure regulatory information is entered into the Clinical Trial Management System (CTMS) and e-Regulatory System
- Work under the supervision of the Clinical Research Manager, UCCC CTO Administrative Director, CTO Medical Director, and Principal Investigators
Requirements:
- Bachelor's Degree
- Nine (9) years of relevant education, experience and/or other specialized training can fulfill minimum education and experience requirements
- SoCRA, ACRP, CHRC or RAPS as applicable
- 5+ years of work experience
- Knowledge of clinical research, human subjects research ethics, and IRB procedures
- Thorough understanding of Good Clinical Practice guidelines, Code of Federal Regulations, clinical trials monitoring, and regulatory compliance
- Strong qualitative skills and knowledge of study design
- Knowledge of medical terminology and policies and regulations relevant to oncology clinical trials
- Excellent verbal and written communication skills
- Ability to interpret and apply University of Cincinnati, UC Health, and federal, state, and local regulations
- Ability to manage multiple priorities, organize, and prioritize work to meet deadlines
- Experience in risk management regarding study subjects, federal and non-federal sponsors, and regulating bodies
- Knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)
- Satisfactory proof of employment eligibility via the Federal I-9 employment verification process if hired
Benefits:
- Comprehensive tuition remission for the employee and eligible dependents
- Robust retirement plans: OPERS, STRS, or Alternative Retirement Plan (ARP), with UC contributing 14–18% of salary based on position
- Vacation and sick time
- 11 paid holidays and additional end-of-year paid time off (Winter Season Days)
- 6 weeks of paid parental leave for new parents
- Competitive salary based on experience
- Comprehensive health coverage (medical, dental, vision, prescription)
- Flexible spending accounts and wellness programs
- Professional development and mentorship opportunities
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