2025-07-17
University of Pittsburgh
Other
/yr
employee
contract
Pittsburgh
Pennsylvania
15260
United States
Clinical Research Operations Specialist - Lead
Position Summary: The Clinical Research Operations Specialist is a critical member of the Office of Clinical Trials, responsible for ensuring fiscal integrity, collaboration with key partners, and consistency in the execution of clinical trial agreements. This position will oversee the application of budget charges to studies, negotiate with sponsors, and work closely with the Sponsored Projects Administration (SPA) contracts specialist. Key Responsibilities: Budget Management and Negotiation: • Apply appropriate budget charges to clinical studies in alignment with study requirements and institutional policies. • Lead negotiations with study sponsors regarding budgetary concerns, ensuring that the institution's interests are upheld while fostering positive sponsor relationships. • Provide study teams with the option to utilize departmental resources or the central office's fee-for-service mechanism for budget negotiations after coverage analysis. Collaboration with SPA Contracts Specialist: • Serve as the primary liaison between the Office of Clinical Trials and the contracts specialist within the SPA. • Facilitate efficient and compliant clinical trial agreement negotiations. • Ensure that all agreements are consistent with institutional standards and regulatory requirements. Standardization and Training: • Regardless of whether support is sourced from the department or the central office, ensure that all tools, templates, and reporting structures utilized are consistent. • Provide training and support to departmental and central office teams to ensure standardized practices and efficient budget negotiation processes. • Continuously evaluate and update tools and templates based on feedback and changing regulations or institutional needs. Reporting and Documentation: • Maintain accurate and comprehensive records of all negotiations, agreements, and related communications. • Generate regular reports detailing the status of ongoing negotiations, finalized agreements, and any challenges faced. Continuous Improvement: Stay updated with industry best practices, regulatory changes, and emerging trends related to clinical trial budgeting and agreements. Provide recommendations for process improvements and efficiency gains within the office • oversees the CTMS platform and ensures seamless integration with research finance operations • supporting study activation, invoicing, compliance, and system optimization • training staff, troubleshooting complex issues, and guiding process improvements.
Minimum Qualifications: • Bachelor's degree in finance, healthcare administration, or related field. • Familiarity with regulatory guidelines related to clinical trials and agreements. • Proficient in clinical trial management software and financial systems• Proficient in clinical trial operations, with a strong emphasis on budgeting and contract negotiations. Familiarity with regulatory guidelines related to clinical trials and agreements.
Prepares and analyzes complex financial statements and handles assigned projects' expenses; prepares complex financial reports and audit analyses. Performs advanced analysis of financials, determines cost saving strategies, and assists with budgetary functions.
Ability to exhibit strong negotiation skills and ability to communicate effectively with both internal teams and external sponsors. Proficient in clinical trial operations, with a strong emphasis on budgeting and contract negotiations. Familiarity with regulatory guidelines related to clinical trials and agreements.
The ability to sit or stand for prolonged periods of time.
The ability to lift up to 25 pounds occasionally.
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
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