Clinical Trial Contract Administrator, COM Dean Office of Clinical Research

Job Overview

The Office of Clinical Research (OCR), a centralized department that works with the UC and UCH research community is seeking to fill two (2) full-time Clinical Trial Contract Administrator positions 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 coverage analysis, 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 contract and budget terms and conditions. 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 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.
• Conduct or carry out work procedures and activities in accordance with industry, local, state, federal, and university regulations; handle sensitive information with confidentiality.
• Contract tracking: remain current on changes to drafts and filing conventions; enter data into University systems; update negotiation status changes within database systems to maintain data integrity and workflow.
• Contract execution: submit final draft of the industry clinical trial contract for approvals and signatures.
• Work with University accountants to ensure proper fiscal account set-up; enter budgets in University database systems as required.
• Work as liaison between departments, sponsors, and team members.
• 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 business operations/law/contract experience, preferably in healthcare, pharmaceutical industry or academic environment
• Thorough knowledge of pre- and post-award industry clinical trial administration, experience negotiating industry clinical trial contracts, and identifying and resolving pre- and post-award obstacles

Additional Qualifications Considered

• 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

Office environment/no specific unusual physical or environmental demands.