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Research Contract Specialist

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Miami, FL

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Description Must have Clinical Trials Negotiating Experience Job Summary: Facilitates preparation and execution of contractual agreements with pharmaceutical, biotechnology, medical device and technology companies, academic institutions, and physician practices. Coordinates efforts to help ensure Research Institute, suppliers, and customers have contractual agreements in place that are clear, fair and legally binding. Oversees and coordinates day to day administrative functions associated with the contracting process within organization's Human Research Protections Program (HRPP) at the Research Institute and the Office of Sponsored Programs (OSP). Minimum Job Requirements: \u00a0Bachelor's Degree Business Administration, or other relevant field required (Required) \u00a02-4 years experience in clinical trials contract negotiation #CA-CM #LI-Priority Qualifications ESSENTIAL JOB DUTIES: \u00a0Ensures clinical research and related activities are performed in accordance with all applicable Federal regulations, Research Institute, NCHS and sponsor policies and procedures. Creates, drafts, and reviews contractual agreements and grant award documents. \u00a0Performs initial and ongoing review and provides comments on contractual agreements received from clients and suppliers including AAHRPP language. \u00a0Prepares contract approval timelines with all parties involved and leads follow-up efforts to obtain contract approval.\u00a0 \u00a0Ensures contracts are accurate, complete, signed by the appropriate parties and submitted in a timely manner. \u00a0Conducts contract negotiations and participates in client interactions. \u00a0Engages with Nicklaus Children\u2019s Health System\u2019s General Counsel as needed to review contract terms and assist with developing research-appropriate contract templates. \u00a0Ensures consistency of terms between informed consent forms and agreements. \u00a0Manages dissemination and filing of contractual agreements through email and contract tracking database. \u00a0Coordinates efforts, as directed, among Research Institute clients (internal and external), suppliers and vendors to facilitate timely execution of agreements \u00a0Maintains up-to-date tracking of all contracts and client correspondence to provide periodic internal updates. \u00a0Prepares ad hoc reports. \u00a0Uses standard computer applications as well as legal\/contract software to standardize and improve departmental processes and tracking. \u00a0Reviews, negotiates, and processes vendor agreements and correspondence as requested by Research Institute and OSP leadership. \u00a0Creates and manages study profiles within the Clinical Trial Management System (CTMS). Assigns internal financial tracking number to each study and communicates with Finance in order to activate the number in Nicklaus Children's Health System's financial system. Job :Clerical\/Administrative Department :Office of Sponsored ProgramsJob Status:Full Time

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