Sr Clinical Research Professional

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 47,000 students, 10,500 faculty and staff and 330,000 alumni, UC combines a Top 35 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, eight straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 athletic conference, UC’s momentum has never been stronger. UC’s annual budget tops $1.6 billion and its endowment totals $1.9 billion.

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 Neurosurgery and Rehabilitation Medicine, is seeking a part-time (50% FTE), senior clinical research professional, to assist in their clinical research.  The incumbent will conduct and support clinical research projects in the area of Stroke.  Duties span a broad range of activities including Stroke. This position will support the University's mission and commitment to excellence and diversity in our students, faculty, staff and all our activities.

This position may offer approximately 1 day per week flexibility for a hybrid remote work option for applicants with a residence within the Cincinnati Tri-State Area.  Hybrid remote work arrangements are subject to change in accordance with university policies, and are dependent on applicant’s ability to maintain “on-call” status during remote work days for urgent on-site research needs.

• 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.
• For nursing focused role, BSN is required. 
• 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.

• Three (3) years of related experience.
• For nursing focused roles, appropriate clinical procedural experience.

• Master’s degree.
• For social work focused role, licensure in the area of clinical specialization.

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

Compensation and Benefits

UC offers a wide array of complementary and affordable benefit options, to meet the financial, educational, health, and wellness needs of you and your family. Eligibility varies by position and FTE.

• 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.

The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.

As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).

The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / Minority / Female / Disability / Veteran.

REQ: 85265 

SF:OMJ SF:RM SF:HEJ, SF:INS SF:HERC SF:DIV SF:LJN