Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.

Job Description:

The Research Contracts & Budgets Specialist will collaborate with OneR operations team and OneOncology practices to support clinical research across the OneOncology network. The Research Contracts & Budgets Specialist is a vital member of the OneR research team responsible for the planning, negotiation, and management of clinical research budgets and contracts. This position requires a strong understanding of clinical trial contracts, processes, financial analysis skills, and the ability to effectively communicate and negotiate with internal and external stakeholders.

Responsibilities

• Review and negotiate clinical trial agreements, including terms and conditions related to budget, payment schedules, and intellectual property rights.

• Provide guidance and support to research staff on interpretation of contract terms and budget-related matters including budgetary constraints.

• Develop and negotiate clinical trial budgets with sponsors and CROs, ensuring alignment with study protocols, regulatory requirements, and institutional policies.

• Analyze proposed study protocols to identify budgetary needs and potential risks.

• Collaborate with cross-functional teams, including OneR leadership, OneOncology legal team, research finance department, and participating site investigators and research managers to ensure accuracy and compliance in budget and contract negotiations.

• Partner with regulatory department in review of informed consent documents to ensure contract and budget alignment.

• Ensure CMS regulations, FDA guidance, and ethical policies are applied to medicare coverage analyses and budget negotiations.

• Track and manage changes to study budgets and contracts throughout the lifecycle of clinical trials, including amendments and budget reconciliations.

• Responsible for entering and maintaining budget and other financial information in the CTMS to maintain proper reimbursement and revenue integrity.

• Maintain standardized fee schedule in the CTMS.

• Maintain accurate and up-to-date records of budget and contract negotiations, approvals, and amendments.

• Stay current with industry trends, regulatory requirements, and best practices related to clinical research budgeting and contracting.

• Participate in process improvement initiatives to enhance efficiency and effectiveness in budget and contract management workflows.

• Responsible for periodic review and revision of OneR policies/processes related to clinical research budget and contract management and provide training and education for staff as needed.

• Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.

Key Competencies

• Strong understanding of clinical trial processes, regulatory requirements (e.g., ICH-GCP, FDA guidelines), and industry standards

• Excellent negotiation skills with the ability to resolve conflicts and reach mutually beneficial agreements

• Exceptional attention to detail and organizational skills

• Excellent communication skills, both verbal and written, with the ability to effectively interact with stakeholders at all levels

• Ability to work independently and collaboratively in a fast-paced environment

Qualifications

• Minimum of 3-4 years of clinical research budget and contract experience

• Paralegal experience preferred

• Bachelor’s degree in a relevant scientific discipline required

• Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS) preferred

• Certification in clinical research (e.g., SoCRA, ACRP) is a plus.

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