Clinical Research Professional, Department of Dermatology
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. 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.
- Initiate and/or assist with developing and revising policies and procedures for nursing practice.
- 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 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.
- Prepare, develop, review and negotiate 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.
- 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.
- 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.