Clinical Trial Contract Administrator, Office of Clinical Research

University of Cincinnati - Cincinnati, OH

Part-time - Mid Level

Remote - Cincinnati, OH

10,001+ employees

Educational Services

About the position

The Office of Clinical Research at the University of Cincinnati is seeking a Clinical Trial Contract Administrator to support the processing and execution of new and amended clinical trial agreements. This role is crucial for enabling research teams at the University to engage with external sponsors and other parties in a manner that is safe, compliant, and effective. The position offers flexibility for partial remote work, with a part-time in-office presence expected at the Clifton location. In this role, the Clinical Trial Contract Administrator will be responsible for reviewing, redlining, and negotiating the terms and conditions of industry clinical trial contracts. This includes direct interaction with sponsors' legal and contracting staff to prepare working and final drafts of contracts. The administrator will also advise faculty, department staff, management, and co-workers on process-related topics, effectively communicating the status of contract negotiations and pending items. It is essential to ensure proper administrative stewardship throughout the life of a contract, which may involve consulting with the University's legal counsel and advocating for the University's interests during negotiations with external entities. The position requires conducting work procedures in accordance with industry, local, state, federal, and university regulations, while handling sensitive information with confidentiality. The administrator will be responsible for contract tracking, ensuring that they remain current on changes to drafts and filing conventions, entering data into University systems, and updating negotiation status changes within database systems to maintain data integrity and workflow. Additionally, the role involves submitting final drafts of industry clinical trial contracts for approvals and signatures, as well as working with University accountants to ensure proper fiscal account setup and entering budgets into University database systems as required.

Responsibilities

• Review, redline, and negotiate industry clinical trial contract terms and conditions.
• Interact with sponsors' legal and contracting staff.
• Prepare working and final draft(s) of contracts.
• Advise faculty, department staff, management, and co-workers on 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 the University's legal counsel.
• Advocate the University's interests in negotiations with external entities.
• Conduct work procedures in accordance with industry, local, state, federal, and university regulations.
• Handle sensitive information with confidentiality.
• Track contracts and remain current on changes to drafts and filing conventions.
• Enter data into University systems and update negotiation status changes within database systems.
• Submit final drafts of industry clinical trial contracts for approvals and signatures.
• Work with University accountants to ensure proper fiscal account setup and enter budgets in University database systems.

Requirements

• 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.
• Previous experience in clinical trial administration, contract execution, business operations, and/or law.
• Preference for experience with healthcare, pharmaceutical industry, and/or academic environments.

Nice-to-haves

• Effective verbal, written and interpersonal communication skills.
• Strong analytical skills, attention to detail, problem solving and organizational skills.
• Advanced proficiency in computer software (Microsoft Office).
• Ability to interact effectively with pharmaceutical companies and clinical research organizations.
• Demonstrate diplomacy, tact and professional demeanor.
• Familiarity with the Federal Drug Administration (FDA), intellectual property, export control, and technology compliance regulations.

Benefits

• 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 life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
• Generous paid time off options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
• Tuition remission available for employees and their eligible dependents.
• Discounts for on and off-campus activities and services.