Clinical Trial Contract Specialist, COM, Dean's Office of Clinical Research

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 are transforming the world of medicine every day.

The Office of Clinical Research (OCR), a centralized department that works with the UC and UC Health research community, is seeking to fill a full-time Clinical Trial Contract Administrator position in the College of Medicine. This position would work with several teams within the OCR, collaborating with budgets, contracts and other processes to facilitate the start of clinical research studies. The selected candidate will work on clinical trial agreements, and ensure smooth processes related to negotiations, start-up timelines, and study team communication.

This position includes the flexibility for partial remote work. Part-time in-office presence at the Clifton location is expected.

Essential Functions

• Review, redline, and negotiate industry clinical trial contracts. Interact with sponsors’ legal, budget and contracting staff. Prepare working and final draft(s) of documents.
• Advise faculty, department staff, management, and co-workers in process-related topics; communicate effectively regarding contract and budget negotiation status and pending items; advise sponsors, external constituents, and other staff to ensure proper administrative stewardship throughout the life of a contract.
• Consult and triage complex terms with University’s legal counsel; advocate the University’s interests in negotiations with external entities.
• Work with budget administrators to ensure the best and correct budget option(s) are in place prior to execution.
• Conduct or carry out work procedures and activities in accordance with industry, local, state, federal, and university regulations; handle sensitive information with confidentiality.
• Track contracts and budgets. Remain current on changes to drafts and filing conventions, enter data into University systems, and update negotiation status changes within database systems to maintain data integrity and workflow.
• Execute contracts and submit final drafts of the industry clinical trial contract for approvals and signatures.
• Work with University accountants to ensure proper fiscal account set-up.
• Work as liaison between departments, sponsors, and team members including scheduling and managing teleconferences with sponsors in a professional manner.
• Track metrics and email inboxes to facilitate timely turnaround times.

Required Education

• Bachelor's Degree in English, Legal Assisting, Business Administration, or 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 clinical research, law, or contract experience.

Additional Qualifications Considered

• Industry clinical trial administration, experience negotiating industry clinical trial contracts, and identifying and resolving startup and operational obstacles, ideally in healthcare, pharmaceutical industry or academic environment.
• Experience negotiating industry clinical trial contracts. Familiarity with the Federal Drug Administration (FDA), intellectual property, export control, and technology compliance regulations.
• Effective verbal, written, and interpersonal communication skills. Strong analytical skills, attention to detail, problem solving, and organizational skills. Advanced proficiency in Microsoft Office.
• Ability to interact effectively with pharmaceutical companies and clinical research organizations, and to work collaboratively with university departments. Demonstrate diplomacy, tact and professional demeanor.

Physical Requirements/Work Environment