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 doctors and faculty are transforming the world of medicine every day. The Department of Neurology & Rehabilitation Medicine is a top-tier department with world-renowned faculty and staff. With world-class research, teaching and medical practice opportunities, why not choose the University of Cincinnati College of Medicine?

University of Cincinnati (UC) is one of the largest employers in the Cincinnati region, employing over 15,000 full-time and part time faculty, staff and student workers.

Founded in 1947, the UC Department of Neurology and Rehabilitation Medicine is revolutionizing medicine by connecting discovery and education to world-class care in neurological diseases. Our vision is to be the model organization that integrates neurologic clinical care, research and education. 

UC’s Department of Neurology and Rehabilitation Medicine is seeking full-time Clinical Research Professional II to assist in their clinical research for their cognitive department located on UC’s medical campus. The incumbent will plan, evaluate, coordinate and/or manage elements of multiple or complex clinical research projects for a designated department, program, or central unit. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.

Essential Functions

• Provide direction, instruction and guidance to coordinate research activities, including patient screening and recruitment, enrollment and education. Ensure protocol procedures have been completed adhering to Good Clinical Practice Guidelines as defined by the Federal Drug Administration (FDA) and serve as subject matter expert.
• Coordinate nursing/social work and patient care and/or patient follow-up functions of the clinical study, including planning and developing related activities. Provide quality patient care to patients and their families within area of clinical specialty.
• Collaborate with care coordinators, social workers, psychologists, physicians and other appropriate treatment team members in diagnostic formulation, treatment direction, and recommendations. Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
• Assist with developing and revising policies and procedures for the research team to ensure compliance with the protocol.
• Serve as a resource within the department for the development of less experienced team members.
• Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency.
• Ensure compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.
• Work closely with UC and UC Health offices in negotiation of contracts, confidentiality agreements and amendments related to the conduct of research activities.
• Work with necessary parties to identify compliance, legal, IP and business/financial risk. Mitigate risk through working with physicians/faculty, divisions, legal and/or other departments.
• Review industry and sponsored research clinical trial budgets for consistency with UC/UCPC policies and operating procedures.
• Prepare, submit, and assist Director with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms). Prepare and maintain FDA applications for Investigational New Drugs (INDs). Maintain regulatory documentation.
• Conduct internal audits.
• Make and assist in modifying protocols and study documents.
• Write reports, business correspondence, and procedure manuals. Create data entry instructions and train data entry specialists. Assist with creation of case report forms.
• Create, test, and perform basic maintenance for databases.
• Act as liaison between study personnel and data entry specialists. Perform quality checks on data entered by others.
• May serve as a resource person or act as a consultant within area of clinical and/or regulatory expertise.
• Assist with preparing, developing, reviewing and negotiating industry and sponsored research clinical trial budgets for consistency with UC/UCPC policies and operating procedures.
• Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

• Bachelors Degree.
• Seven (7) years of relevant education, experience and/or other specialized training can fulfill minimum education and experience requirements.

Required Experience

Three (3) years relevant experience.

Physical Requirements/Work Environment