Research Contract Analyst
Summary
Prepares, negotiates, and executes clinical trial contracts for a major hospital, ensuring legal compliance and timely approvals while coordinating with sponsors and internal teams.
This position, under the guidance of a Research Contract Analyst Lead, is responsible for preparation, negotiation, and execution of contractual agreements with trial sponsors on behalf of TGH while working with cross-functional departments to meet client deliverables. Responsible for performing job duties in accordance with mission, vision and values of the Office of Clinical Research and Tampa General Hospital.
•Reviews draft contract documents, including Start-up Agreements, Work Orders and Change Orders, etc. from sponsor/grantor provided templates per guidance provided by the Research Contract Analyst Lead and in conjunction with relevant departments.
•Facilitates the negotiation of CDAs by reviewing sponsor CDAs and negotiate within CDA review guidelines, including coordination with TGH’s legal and business department to ensure timely agreements.
• Drafts and edits contractual agreements based upon existing standard templates and policies
• Communicates with legal counsel as needed
• Directs sponsor interaction with new and established contacts per guidance provided by the Research Contract Analyst Lead.
• Review sponsor contractual templates and edit as appropriate to ensure TGH’s positions are covered and to highlight areas of potential concern.
• Ensures contracts show all the appropriate TGH edits before sending to the sponsor.
• Ensures contractual documents are processed and maintained in relevant databases.
• Provides quality deliverables in accordance with strict deadlines.
• Prepares contract approval timelines with all parties involved and leads follow-up efforts, as directed, to obtain contract approval.
• Negotiates and releases contract language in accordance with project requirements and TGH and industry standards.
• Manages dissemination and filing of contractual agreements.
• Coordinates efforts, as directed, among TGH clients, suppliers and outside counsel to facilitate timely execution of agreements.
• Maintains up-to-date tracking of all contracts and client correspondence and provides periodic internal updates.
• Participates in the development and testing of tools and procedures
• Prepares ad hoc management reports as required.
• Leads or participates in client and team calls.
• Participate in contract review meetings.