Senior Clinical Research Professional, Department of Neurology & Rehabilitation Medicine, Stroke

Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPL

 

Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls “the most ambitious campus design program in the country.”

 

With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, nine straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC’s momentum has never been stronger. UC’s annual budget tops $1.65 billion and its endowment totals $1.8 billion. The University’s overall regional economic impact exceeds $10.6 billion, paving the way for the future of Cincinnati.

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 improves 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 and staff are transforming the world of medicine every day.

 

The University of Cincinnati, College of Medicine, Department of Neurology and Rehabilitation Medicine, is seeking a senior clinical research professional, to assist in their clinical research.  Duties span a broad range of activities. This position will support the University's mission and commitment to excellence in our students, faculty, staff and all our activities.

Essential Functions

• 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