Job Title: Clinical Research Operations SpecialistLocation: Onsite in Pittsburgh BUT could consider remote for right candidate ONLY 12-month contractType:12-month contract or Permanent ONLY for local candidates or ones relocating to PittsburghHourly rate: $32 to $40 an hr for 12-month contract and annual salary for permanentOverview:Our client is seeking a Clinical Research Operations Specialist who will be a critical member of their 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.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
Minimum Requirements:
Bachelor's degree in finance, healthcare administration, or related field. Advanced degree or certification in clinical research preferred.
Minimum of [X years] experience in clinical trial operations, with a strong emphasis on budgeting and contract negotiations.
Familiarity with regulatory guidelines related to clinical trials and agreements.
Strong negotiation skills and ability to communicate effectively with both internal teams and external sponsors.
Proficient in clinical trial management software and financial systems
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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
