Clinical Research Team Lead, Regulatory, COM UC Cancer Center

Job Overview

As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children’s Hospital Medical Center, College of Medicine’s faculty are transforming the world of medicine every day.

The University of Cincinnati Cancer Center (UCCC) Clinical Trials Office (CTO) is an institutional resource within the University of Cincinnati College of Medicine and UC Health that provides administrative, nursing, and data management support for cancer clinical trials conducted by UC Investigators. The Clinical Research Team Lead (Regulatory) oversees the implementation and regulatory maintenance of clinical trials in the CTO. The Clinical Research Team Lead will provide expert level knowledge in clinical trial practices and regulations and ensures compliance. Working under the direct supervision of the Clinical Research Manager, UCCC CTO Administrative Director and CTO Medical Director as well as Principal Investigators to ensure safe implementation of oncology clinical trials.

Essential Functions

The Clinical Research Team Lead has duties that include but are not limited to:

• Guides and directs day-to-day functions of a team of regulatory clinical research professionals assigned to support the various disease teams within the Clinical Trials Office.
• Provides support, direction and coaching to the regulatory team in the areas of training, problem resolution, planning, and work assignment delegation.
• Demonstrates the capacity and routinely serves as a subject matter expert for research regulatory activities, procedures, and adherence to Good Clinical Practice Guidelines.
• Provides input for performance evaluations as needed and serves as contact for scheduling needs.
• Able to provide coverage for direct reports or lower-level staff as needed.
• Contribute to the development of new processes, procedures, tools, and training to enhance clinical research activities.
• In collaboration with management team and principal investigator, provide guidance to team members in the management of non-compliant data collection or study activities including input on course of action to address/resolve and avoid future non-compliance.
  Track progress on research studies within purview and develop prioritization plans for work of team.
• Work with study sponsors, IRB, and other regulatory offices as needed.
• In collaboration with the Regulatory Manager, the Team Lead is responsible for ensuring protocols are appropriately shepherded through the regulatory process in order to meet the goal of protocol activation for research participant accrual in accordance with institutional and federal (National Cancer Institute) requirements.
• Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment.
• Oversees adherence to SOPs, Good Clinical Practice, and FDA regulations.
• Ensures that regulatory information is entered into the Clinical Trial Management System (CTMS) and e-Regulatory System.

Required Education

• Bachelor's Degree.
• Nine (9) years of relevant education, experience and/or other specialized training can fulfill minimum education and experience requirements.

Required Trainings/Certifications

• SoCRA, ACRP, CHRC or RAPS as applicable.

Required Experience

• 5+ years of work experience.

Additional Qualifications Considered

• 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, regulatory compliance. Strong qualitative skills and knowledge of study design.
• Knowledge of medical terminology as well as the policies and regulations relevant to oncology clinical trials.
• Excellent verbal and written communication skills in daily interactions with the ability to interpret and apply University of Cincinnati, UC Health policies 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).
  

Physical Requirements/Work Environment