Revival Research Institute, LLC
Location
Southfield, MI | United States
Job description
Primary Purpose:
To manage, review, and negotiate clinical research contracts and budgets, ensuring the institution's clinical trials are appropriately funded and executed in line with legal, regulatory, and institutional standards.
Key Responsibilities:
Contract Management :
• Conduct a comprehensive review of clinical trial agreements, confidentiality agreements, service contracts, and related documents.
• Track contract progress, from initial contract to execution, ensuring timely processing and adherence to deadlines.
Budget Oversight:
• Collaborate with clinical trial teams to analyze study protocols and derive detailed budget estimates based on anticipated procedures, resources, and duration.
• Negotiate budgetary terms with study sponsors, ensuring adequate compensation for all trial activities and overhead.
• Monitor trial expenditures regularly, comparing actual costs against budgeted amounts and addressing any discrepancies.
Regulatory Compliance :
• Continuously monitor regulatory changes at local, state, and federal levels, and update contract and budget procedures accordingly.
• Ensure all agreements are compliant with applicable regulations, such as Medicare rules, fair market value considerations, and patient privacy protections.
Inter-departmental Coordination :
• Serve as the primary liaison between the clinical research department and other internal departments, such as legal, finance, and procurement.
• Organize and lead cross-functional meetings to address complex contractual or budgetary issues, ensuring alignment across all stakeholders.
Documentation :
• Implement and manage a centralized contract management system, ensuring that all contracts, amendments, and related documents are securely stored and easily accessible.
• Generate regular reports on contract status, budget utilization, and forecasted financial needs.
Stakeholder Communication :
• Establish and maintain open lines of communication with study sponsors, addressing any concerns or questions related to contracts or budgets.
• Provide training and guidance to internal stakeholders on contract and budget procedures, ensuring a consistent approach across the organization.
Continuous Improvement :
• Analyze internal processes to identify inefficiencies or areas of risk related to contracts and budgets.
• Develop and implement strategies to optimize processes, leveraging best practices and technology solutions.
Qualifications:
Education : Bachelor’s degree in Business Administration, Finance, Healthcare, or a research-related field. Advanced degrees or certifications in clinical research, contract management, or legal studies are highly desirable.
Experience : Minimum of 3-5 years of experience in contract management and/or budgeting, preferably within a clinical research or healthcare setting.
Skills:
• Proficient in contract management software, financial software, and MS Office suite.
• Strong analytical skills with the ability to interpret complex contractual language and financial data.
• Exceptional negotiation skills and the ability to diplomatically manage stakeholder expectations.
• Ability to manage multiple projects simultaneously, prioritizing tasks to meet strict deadlines.
• Comprehensive understanding of clinical trial methodologies, procedures, and regulatory standards.
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