Clinical Research Professional I or II, Department of Radiology

Clinical Research Professional I Or II, Department Of Radiology

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

Required Experience: Three (3) years relevant experience

Physical Requirements/Work Environment: Office environment/no specific unusual physical or environmental demands.

Compensation and Benefits: UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. Highlights include: comprehensive tuition remission, robust retirement plans, real work-life balance, additional benefits include competitive salary, comprehensive health coverage, flexible spending accounts & wellness programs, professional development & mentorship opportunities.