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

University of Cincinnati; Cincinnati (OH); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Tuition remission

Retirement plans

Health coverage

Job summary

The University of Cincinnati Office of Clinical Research (OCR) seeks a full-time Clinical Trial Contract Administrator to negotiate industry contracts, coordinate with sponsors, and manage start-up timelines within the College of Medicine. Partial remote work is allowed with in-office Clifton presence.

Ideal candidates have a Bachelor’s in a related field and at least two years in clinical research, law, or contracts, plus strong communication and budget skills. Equal opportunity employer.

Qualifications

• Bachelor's degree in listed fields.
• Two years of clinical research, law, or contract experience.
• Six years of related work experience may substitute education.

Responsibilities

• Review, redline, and negotiate industry clinical trial contracts.
• Advise faculty, department staff, management, and co-workers on contract & budget negotiations.
• Track contracts and budgets; enter data into university systems and update negotiation status.

Skills

Contract negotiation

Budget management

Communication

Regulatory awareness

Process improvement

Education

Bachelor's degree in English, Legal Assisting, Business Administration, or related field

Six years of related work experience in lieu of education

Tools

Microsoft Office

Job description

Current UC employees must apply internally via SuccessFactors

Next Lives at the University of Cincinnati

Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. Home to more than 53,600 students, 12,000 faculty and staff, and over 360,000 living alumni, UC, a Carnegie 1 institution, combines research prowess with a physical setting The New York Times has called "the most ambitious campus design program in the country." UC's momentum has never been stronger as the anchor of the Cincinnati Innovation District, the oldest cooperative education (co-op) program in the country with students earning $94 million annually through paid experiences, an academic health system, and as a member of the Big 12 Conference. The university contributes $10.6 billion in economic impact to the city and $22.7 billion to the state of Ohio. At UC, next is all of us. Learn more at uc.edu.

UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC’s success.

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 and 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

• Office environment/no specific unusual physical or environmental demands.

Compensation And Benefits

Comprehensive Tuition Remission

UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university.

Robust Retirement Plans

As a UC employee, you won’t contribute to Social Security (except Medicare). Instead, you’ll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 14-18% of your salary based on position.

Real Work-Life Balance

UC prioritizes work-life balance with a generous time-off policy, including:

• Vacation and sick time
• 11 paid holidays and additional end-of-year paid time off (Winter Season Days)
• 6 weeks of paid parental leave for new parents

Additional Benefits Include

• Competitive salary based on experience
• Comprehensive health coverage (medical, dental, vision, prescription)
• Flexible spending accounts & wellness programs
• Professional development & mentorship opportunities

To learn more about why UC is a great place to work, please visit our Careers Page.

UC is an E-Verify employer. If hired into this position, you will be required to provide satisfactory proof of employment eligibility by providing acceptable, original forms of identification for employment verification via the Federal I-9 employment verification process. Click here for a list of acceptable documents.

Equal Opportunity Employer. Building a workplace where all qualified applicants will receive consideration for employment, including Individuals with Disabilities and Protected Veterans.