Clinical Research

• 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

Clinical Research Professional II, Neurology – Rehabilitation Medicine

Clinical Research Project Manager, Radiology

Clinical Research Professional III, Neurology & Rehabilitation Medicine – Stroke

Clinical Research Professional II, Radiology

Clinical Research Professional, Biorepository