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 doctors and faculty are transforming the world of medicine every day. The Department of Neurology & Rehabilitation Medicine is a top-tier department with world-renowned faculty and staff. With world-class research, teaching and medical practice opportunities, why not choose the University of Cincinnati College of Medicine?

UC is one of the largest employers in the Cincinnati region, employing over 15,000 full-time and part-time faculty, staff and student workers.

Founded in 1947, the UC Department of Neurology and Rehabilitation Medicine is revolutionizing medicine by connecting discovery and education to world-class care in neurological diseases. Our vision is to be the model organization that integrates neurologic clinical care, research and education. 

The University of Cincinnati, College of Medicine, Department of Neurology and Rehabilitation Medicine is seeking a Full-Time Research Compliance Specialist. The Research Compliance Specialist will work in the NIH StrokeNet National Coordinating Center (NCC) and serve as a liaison between the StrokeNet Central IRB or Commercial Central IRB and participating StrokeNet Sites. 

Essential Functions

• Serve as liaison for designated research protocols/studies; perform initial/ongoing research protocol reviews and provide advice to the Board/Committee; perform protocol audits as required; attend Board/Committee meetings to review and discuss studies to ensure compliance with federal, state, local regulations, and University policies & procedures; act as a resource for Board/Committee members regarding regulations during research protocol review. Resolve all issues involving research protocols.
• Interpret, analyze and apply federal, state and local regulations, along with University rules and regulations, to ensure ethical research practices are followed; report suspected or known instances of noncompliance with University or federal regulations.
• Coordinate information to meet protocol-reporting requirements; resolve routine and non-routine issues involving research protocols including direct communication with investigators and research staff; interact with investigators, faculty, students and administration of all levels.
• Serve as the sponsor representative for Network trials to interact with performance sites, the trial Project Manager, National Data Management Center (NDMC) and cIRB staff to facilitate review of documents for protocol compliance for cIRB submission and other protocol related regulatory issues.
• Use independent judgment to, interpret, analyze and perform the sponsor’s review in collaboration with the NCC Project Manager, the NDMC staff, the StrokeNet CIRB, and the trial investigator sponsor.
• Assist in the resolution of non-routine protocol related issues in coordination with the project manager, trial and site investigators, the NDMC, the CIRB, and sites’ research staff.
• Assist in the development and maintenance of daily operational policy and procedures.
• Provide training and mentoring as needed, may conduct on-site audits; may serve as full member on review board/committee.
• Responsible for attending or participating in various NCC and NINDS meetings, webinars and teleconferences.
• Work with the NCC leadership to accomplish the necessary NCC tasks, in addition to short- and long-term goals.
• Perform related duties based on departmental need. This job description can be changed at any time. 

Required Education

• Bachelor’s Degree must be in a related field.
• Six (6) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Experience

Two (2) years of experience in a compliance, basic science and/or clinical research environment.

Additional Qualifications Considered

• Relevant professional certification or an advanced degree.
• Strong verbal and written communication, customer service, and computer and data entry skills.
• Familiar with standard concepts, practices, and procedures dealing with federal assistance awards.
• Prioritize work, work independently, and manage a variety of projects simultaneously.
• Good time-management skills and be organized and detail-oriented.
• Recognize the need for change; respond with flexibility to changing program demands; propose solutions; and assist with implementation.
• Demonstrate dependability, reliability, and excellent attendance record.
• Exhibit patience, objectivity, maturity, effectiveness under stress, initiative, adaptability, leadership, and sound judgment.

Physical Requirements/Work Environment