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Organization TypePublic Interest
Years of Experience
Date Last Verified
ProfileResearch Contract Specialist Responsibilities: Responsible for supporting coordinated and compliant reviews of Allina Health research agreements, amendments, and work orders with research sponsors and various other research contractors. Legal review and coordinator for research agreements, amendments, and work orders between Allina and research sponsors according to Allina Health established contracting guidelines. Coordinate agreement reviews between researcher managers/directors and study sponsors and if necessary, with input from legal, risk management, research compliance, and leadership, according to established department guidelines. Serve as the primary reviewer on research agreements. Serve as the main point of contact for research manager/directors. Reviews agreement with support from Sr. Research contract specialist. Escalate issues and questions to Legal and/or department management as needed per established guidelines and informed judgment. Legal review and coordination of provider and non-provider agreements between Allina and independent contractors. Draft and review other research agreements including provider and non-provider service agreements. Serve as primary Contract Admin Designee for research provider arrangements. Work closely with key internal stakeholders on developing a process for intake of these agreements, review process, and execution. Work closely with Research Operations Manager and internal stakeholders to develop agreement submission, review, and approval/signature guidance, tools, and processes. Support development of guidance for internal contracting standards and/or research site requirements in collaboration with Research Operations management and key stakeholders including Legal and Risk. Assist in development and implementation of contract review tools and process guidance. Assist in development and execution of communication plans for new or updated process roll-out. Initiate, participate in, and contribute to process improvements. Organization, tracking, and communication of agreement progress and/or issues. Maintain tracking log of all agreement reviews and progress. Maintain regular tracking and reporting of Research Operations agreement review metrics. Organize and manage regular meetings and/or progress notifications with research sites and Research Operations management to review issues and/or communicate on progress. Effectively communicate and collaborate within a matrixed environment with varying professional levels. Function as key resource/subject matter expert on research contracting issues and processes. Assist Sr. Research Contract Specialist, Research Operations Manager, researchers and other internal stakeholders in resolving complex research contracting and contract management issues. Liaison between research sites and internal stakeholder areas to ensure research contracting compliance and updates are communicated (insurance for non-employed physicians). Stay apprised of important changes in federal clinical research guidance and regulations. Provide ongoing support and collaborate in the development of process education to internal researchers. Work closely with the Sr. Research Contract Specialist and Research Ops management in the development of education as it relates to research agreements. Assist in the development of yearly education plan as it relates to research agreements and/or regulations. Assist in the delivery of education as needed. Support Research Administration and Research Compliance with special projects and/or requested duties as assigned.
Qualification and Experience
Qualifications: JD Degree required. 3-4 years’ experience in research, healthcare, legal, or compliance. 2+ years' experience in contract review. Demonstrated experience in project and/or process management. Ability to interpret government requirements/regulations and strong business acumen. Excellent writing and oral communication skills. Experience leading teams and/or collaborative process improvement. Critical thinking and analytical skills. Detail oriented. Preference for: Knowledge of clinical research, research compliance, and/or research contracting. Contract negotiation experience. Experience with government regulations related to research: 21 CFR 50/56 - Human subject protection and/or Institutional Review Boards, 21 CFR 312/812 - Investigational New Drug/Investigational Device Exemption, 45 CFR 46 – Protection of Human subjects, 2 CFR 200 – Grants and Agreements, Medicare/CMS Clinical Trial Policy (CTP) or National Coverage Decision. Experience with policy/process development. Experience providing education and training.
Requisition # 35786BR