University of Cincinnati Cancer Center in Cincinnati, OH is seeking to hire a Clinical Research Manager to join the Clinical Trials Office leadership team.
The Clinical Research Manager oversees the implementation of clinical trials in the Clinical Trials Office (CTO). The Clinical Research Manager provides expert level knowledge in clinical trial practices and regulations and ensures compliance. Working under the direct supervision of the University of Cincinnati Cancer Center CTO Administrative Director and CTO Medical Director as well as Principal Investigators to ensure safe implementation of oncology clinical trials.
Guides and directs a team of clinical research nurses and coordinators assigned to the various disease teams within the Clinical Trials Office.
Provides support, direction and coaching to clinical research coordinators in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
Provides daily management/supervision to the clinical research coordinators to promote maximum enrollment, safe participation and exemplary conduct, and generation of accurate and complete data of the clinical research activities within the Clinical Trials Office.
Oversees adherence to SOPs, Good Clinical Practice, and FDA regulations.
Ensures that accrual data and each subject data is entered into the Clinical Trial Management System (CTMS).
Assists CTO leadership in developing strategic planning goals and initiatives for clinical research.
Liaises and works efficiently in collaboration with the CTO Associate Director of Operations and with other departments at the University to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation.
Interacts on a daily basis with the CTO Regulatory Manager, CTO Data and Quality Assurance Manager, CTO Associate Director of Operations to ensure all protocol requirements are met.
Works with study sponsors, IRB, and other regulatory offices as needed.
Other duties as assigned.
Minimum Qualifications: Bachelor’s degree required, preferably in related discipline or equivalent education/experience; 5-10 years of directly relevant experience, preferably in an academic or clinical setting
Additional Qualifications Considered:
Master’s degree with at least 3 years of supervisory experience
Nursing Degree and experience with management of oncology trials
Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRP) certification
Knowledge of medical terminology as well as the policies and regulations relevant to oncology clinical trials
Ability to build, lead, motivate, and assess a professional team
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)