Clinical Contract Associate Ii

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Clinical Contract Associate II
Duties: Perform a variety of activities involved in the drafting of contracts for clinical research studies. Monitor/review proposed contracts for compliance with applicable company policy as well as applicable regulations. Write technical contract language covering such issues as indemnification, subject injury language, intellectual property rights, confidentiality, fiscal/procedural constraints, and other similar matters. Maintain up-to-date Legal Department reference file. Analyze and resolve technical problems of contract interpretation and resolves conflicts as necessary. Participate in policy discussions and recommends policy or procedural changes as appropriate; revise and update procedures as necessary. Work in conjunction with manager to ensure contractual requirements and timelines are met; ensure adherence to those timelines; communicate milestones and commitments. Meet study site activation timelines utilizing effective negotiations skills which results in signed executable agreements Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Support and collaborate with the internal and external stakeholders to achieve departmental goals and the implementation of mitigation strategies to ensure timelines are met. Ensure all clinical site contract comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance). Identify issues/problems and provides customary recommendations for solutions. May focus on either contracts or grants or both areas based on Business Unite needs. Work on diverse business problems that require financial analysis with oversight from more senior individuals in department. Assists clinical teams in resolving financial issues as they relate to site contracts. Coordinate the preparation, execution, and tracking of domestic clinical site agreements, including study-specific budget templates, contracts and other documents with specific guidance from senior individuals. Work closely with internal clinical teams to ensure rapid start-up of study sites. Be responsible for tracking the progress of study-start-up activities as it relates to contracts and budgets. Be responsible for the preparation and ongoing review of study documents throughout the lifecycle of the clinical trial. Perform routine work under moderate supervision without detailed instructions and complex tasks under general supervision. Collaborate with management to generate and track metric reports. Demonstrate moderate proficiency in the understand complex budgeting & forecasting tools. Interact well with clinical teams, legal, and payments team. Advise manager regarding potential issues. Identify course of action and work in conjunction with management to implement. Create, prepare, review and edit contracts, Master Agreements, statement of work , amendments, modifications and change contract changes of a high complexity level and contract risk type. Analyze documents to determine corporate risk; prepare and provide alternative approaches to mitigate the risk. Solve unique and complex problems with broad impact on the business; requires conceptual and innovative thinking to develop solutions. Maintain communication of negotiation status using Company IT systems. Obtain necessary approvals for contractual documents by senior management. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

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