Clinical Research Professional II, Department of Urology

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 improve 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. The Department of Urology (previously the Division of Urology) is developing into a top-tier department.

The department is looking to bring on a Clinical Research Professional II. This role can expect to plan, evaluate, coordinate and/or manage elements of multiple or complex clinical and translational 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/translational research spectrum.

Essential Functions

•Provide direction, instruction and guidance to coordinate research activities, including interfacing with the IRB, patient screening and recruitment to studies, enrollment, biospecimen collection, ensuring completion of data forms 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.
•High level of communication with patients and family members and ability to answer questions in an understandable manner.
•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 the department 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