Clinical Research Professional/Senior Clinical Research Professional, Internal Medicine, Nephrology
University of Cincinnati
- Cincinnati, OH
- Permanent
- Full-time
- 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.
- 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.
- Initiate and/or assist with developing and revising policies and procedures for nursing practice when related to research protocols. Educate clinical nursing staff to protocols and their requirements.
- Serve as a peer-mentor within the department, supporting management and in various responsibilities as appropriate including 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 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.
- Prepare, submit, and assist Director with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
- Make and assist in modifying 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.
- Database creation, testing, and basic maintenance.
- 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.
- Bachelor’s Degree must be in a related field.
- Five (5) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
- Bachelor’s Degree must be in a related field.
- Seven (7) years of relevant work experience and /or other specialized training can be used in lieu of education requirement.
- For nursing focused role, BSN in the area of clinical specialization, and RN License in State of Ohio.
- For social work focused role, licensure in the area of clinical specialization.
- One (1) year of related experience.
- Three (3) years of related experience.
- Master’s degree.
- Experience in an academic or clinical setting in the area of clinical specialization.
- Sitting - Continuously
- Competitive salary range dependent on the candidate's experience.
- Comprehensive insurance plans including medical, dental, vision, and prescription coverage.
- Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.
- Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
- Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
- Tuition remission is available for employees and their eligible dependents.
- Enjoy discounts for on and off-campus activities and services.