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Research Contracts

3 months ago

Nashville, United States Medix™ Full time

Job description

Positioning community of oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. Our team is bringing together leaders to the market place to help drive our mission and vision. 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 the operations team and practices to support clinical research across the oncology network. The Research Contracts & Budgets Specialist is a vital member of the 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 the leadership, 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 the 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.