Clinical Trial Contract Administrator, Office of Clinical Research

Job Description

About the Role

Title: Clinical Trial Contract Administrator, Office of Clinical Research

Location: Cincinnati United States

Job Description:

The Office of Clinical Research is seeking to fill a Clinical Trial Contract Administrator position in the University of Cincinnati’s College of Medicine. This position supports the processing and execution of new and amended clinical trial agreements. These agreements allow research teams at the University of Cincinnati to engage with external sponsors and other parties to conduct clinical research in a safe, compliant, and efficacious manner.

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 terms and conditions. Interact with sponsors’ legal and contracting staff. Prepare working and final draft(s) of contract.

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.

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

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

Additional Qualifications Considered

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, and to work collaboratively with university departments. Demonstrate diplomacy, tact and professional demeanor.

Familiarity with the Federal Drug Administration (FDA), intellectual property, export control, and technology compliance regulations is ideal.

Physical Requirements/Work Environment

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.