Research Contract Analyst
Clinical Research
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 policie
• 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 procedure
• Prepares ad hoc management reports as required.
• Leads or participates in client and team calls.
• Participate in contract review meetings.
Qualifications
Bachelor's degree in a related field including paralegal / legal studies and at least two (2) years' of relevant work experience. Clinical trial contracting experience highly preferred. Advanced legal training/coursework preferred
• Contract negotiation skills.
• Knowledge of contract management principles.
• Excellent computer skills and comprehensive knowledge of relevant software including MS Word, Excel, PowerPoint, MS Outlook, database software.
• Fluent in English, oral and written.
• Excellent writing capabilities, including the ability to write reports and business correspondence.
• Ability to read, analyze and interpret contractual documents and technical procedures.
• Ability to effectively present information and respond to questions from managers and clients.
• Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists.
• Ability to work independently and work as part of a project team.
• Highly organized with excellent oral and written communication skills.
• Analytical skills, problem-solving skills and attention to detail.
• Confident dealing with internal staff, and external stakeholders as required.
• 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 policie
• 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 procedure
• Prepares ad hoc management reports as required.
• Leads or participates in client and team calls.
• Participate in contract review meetings.
Qualifications
Bachelor's degree in a related field including paralegal / legal studies and at least two (2) years' of relevant work experience. Clinical trial contracting experience highly preferred. Advanced legal training/coursework preferred
• Contract negotiation skills.
• Knowledge of contract management principles.
• Excellent computer skills and comprehensive knowledge of relevant software including MS Word, Excel, PowerPoint, MS Outlook, database software.
• Fluent in English, oral and written.
• Excellent writing capabilities, including the ability to write reports and business correspondence.
• Ability to read, analyze and interpret contractual documents and technical procedures.
• Ability to effectively present information and respond to questions from managers and clients.
• Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists.
• Ability to work independently and work as part of a project team.
• Highly organized with excellent oral and written communication skills.
• Analytical skills, problem-solving skills and attention to detail.
• Confident dealing with internal staff, and external stakeholders as required.