Clinical Research Manager, Education, 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.

A full-time Clinical Research Manager position is available in the UC Cancer Center at the University of Cincinnati College of Medicine. 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, operational, and data management support for cancer clinical trials conducted by UC Investigators. The Clinical Research Manager (Education) leads the development, implementation, and evaluation of education and training programs for CTO personnel and other professionals engaged in human-subjects research, including clinical research coordinators, data personnel, regulatory and quality assurance staff, investigators, and other clinical staff. The position applies expert knowledge of clinical research practices and regulations to promote compliant, consistent, and safe implementation of Phase I-IV oncology clinical trials across disease sites. The incumbent will work under the direct supervision of the UCCC CTO Quality Assurance Manager and works collaboratively with the UCCC CTO Administrative Director and CTO Medical Director, Clinical Research Managers, QA team members, and other departmental and institutional stakeholders.

Essential Functions

• Develop, implement, and evaluate oncology research orientation & training programs for CTO personnel promoting the use of hands-on simulations, team-based multidisciplinary practices and utilizing multiple adult-learner focused strategies.
• Independently design, coordinate, implement and evaluate a variety of formal continuing education programs for research personnel based on identified learning needs, emerging trends in research, regulatory changes, quality findings, and new or revised processes and practices, etc.
• Design, implement, maintain, and evaluate educational platforms and metric-capture systems including Canvas and REDCap to meet CTO educational and training needs and initiatives.
• Prepare and present reports on educational initiatives, learner outcomes, and training metrics for internal and external stakeholders.
• Coordinate the CTO Process Improvement Committee (PIC) ensuring all proposed changes or new policies, workflows, SOPs or other procedural documents are reviewed per the PIC Charter.
• Develop, implement and maintain repositories for all internal CTO policies, workflows and SOPs, including processes for routine review, accuracy verification, staff training, acknowledgment, and renewal.
• Provide in-person instruction in clinical settings on research best practices and departmental expectations for research staff and clinicians.
• Provide training and guidance to CTO Preceptors and evaluate effectiveness of Preceptors (adjusting assignments as needed) in collaboration with Clinical Research Managers.
• Mentor and assist new employees in assimilating successfully into the CTO, ensuring timely communication of any issues to the employee’s direct supervisor and providing required/directed continuing education as applicable in collaboration with the direct supervisor.
• Provide research role-specific training to researcher physicians and APPs external to the department as needed. Includes coordination of Fellows and/or Resident research rotations within the CTO.
• Coordinate obtaining continuing education credits for continuing education offerings through professional societies (e.g., SOCRA, ACRP, RAPS, etc.)
• Oversee adherence and provide guidance related to all relevant internal/external SOPs, policies, and workflows, Good Clinical Practice, and FDA regulations.
• Holds leadership roles in Departmental or Institutional committees relating to clinical research compliance and/or education.
• Provides daily management/supervision to the clinical research education team.
• Assists CTO leadership and QA Manager in developing strategic planning goals and initiatives for clinical research education, quality, compliance, and workforce development.
• Other job duties as needed to support the education and training initiatives of the CTO.

Required Education

• Bachelor’s Degree
• Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Trainings/Certifications

• N/A

Required Experience

• Five (5) years related experience.

Additional Qualifications Considered

• Experience in an academic or clinical setting in the area of clinical specialization.
• SoCRA or ACRP certification.
• Experience in oncology clinical research.
• Strong written, verbal, and interpersonal communication skills with ability to maintain effective communication with internal employees, managers, investigators, and stakeholders as needed.
• Strong analysis and independent problem-solving skills.
• Ability to integrate and apply feedback in a professional manner.
• Ability to prioritize tasks and drive results with a high emphasis on quality.
• Ability to work independently and as part of a team.
• Previous supervisory or management experience.

Physical Requirements/Work Environment