Clinical Research Professional II, COM, Department of Neurology & Rehabilitation Medicine, Cognitive Clinical Research Professional II, COM, Department of Neurology & Rehabilitation Medicine, Cognitive

University of Cincinnati • Cincinnati, OH

105d

About The Position

The University of Cincinnati College of Medicine (COM) is seeking a full-time Clinical Research Professional II to assist in clinical research for the 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.

Requirements

• Bachelors Degree.
• Three (3) years relevant experience.

Nice To Haves

• Phlebotomist training and certification is ideal.

Responsibilities

• 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.

Benefits

• Comprehensive Tuition Remission for you and your eligible dependents.
• Robust Retirement Plans with UC contributing 14–18% of your salary based on position.
• Generous time-off policy, including vacation and sick time, 11 paid holidays, and additional end-of-year paid time off.
• 6 weeks of paid parental leave for new parents.
• Competitive salary based on experience.
• Comprehensive health coverage (medical, dental, vision, prescription).
• Flexible spending accounts & wellness programs.
• Professional development & mentorship opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree