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Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. Home to 53,235 students, nearly 12,000 faculty and staff and 350,000+ living alumni, UC combines a Top 35 public research university with a physical setting The New York Times has called “the most ambitious campus design program in the country.”
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UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC’s success.

JOB OVERVIEW

As one of the oldest medical schools in the country, the UC College of Medicine has a strong reputation for training best-in-class health care professionals and advancing cutting-edge research that improves patient outcomes.
The Department of Emergency Medicine, University of Cincinnati College of Medicine is seeking a full-time (100% FTE) Clinical Research Professional II to provide data analytic support by supporting and maintaining research databases, development of reports, and design, develop and maintenance of REDCap and SQL databases. This position will plan, evaluate, coordinate and/or manage elements of multiple or complex clinical research projects for a 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.

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.

ADDITIONAL QUALIFICATIONS CONSIDERED

Experience with SQL, REDCap, and R or SAS software programs.

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

• Office environment/no specific unusual physical or environmental demands.

• Assist with the coordination of research studies and programs in the Department of Emergency Medicine.
• 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.
• 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 lnvestigational 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.
• Be proficient in most phases of database management including database design, security, and data storage.
• Design and develop databases using REDCap.
• Process data and develop reports on various departmental projects, includes the integration of data from existing data systems and other external data sources.
• Develop programs using R or SAS language or other statistical software for the development of analytical datasets and reports.
• 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.
• Perform related duties based on departmental need. This job description can be changed at any time.