Lead Research Contract Analyst - Research & Education

This position is responsible for facilitating the preparation, drafting, negotiation and execution of contractual agreements with trial sponsors on behalf of Tampa General Hospital (TGH). Coordinates efforts (both internal and external) to help ensure that TGH, its suppliers and customers have contractual agreements in place that are clear, fair and legally binding. In conjunction with management, leads efforts to develop team resources. .Responsible for performing job duties in accordance with the mission, vision and values of Tampa General Hospital. This position will be considered an advanced expert for clinical trial agreements and contracts.

• Identifies opportunities to reduce timelines for complex negotiations with sponsors.

• Liaison with the Joint Research Office to ensure budgets and contracts are efficiently executed with appropriate language and terms.

• Recommends policies and procedures for the operation of the unit and works with more complex cases such as multiple providers, patents and licensing issues, major industrial contracts or export control.

• Oversees the establishment of new contracting processes.

• Creates and delivers educational content for principal investigators, study teams, sponsors and other internal and external customers regarding the contracting process.

• 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 Analyst Lead and in conjunction with relevant departments.

• Facilitates the negotiation and execution of Confidentiality Disclosure Agreements (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

• Directs sponsor interaction with new and established contacts per guidance provided by the Pre-award Manager and legal counsel.

• 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.

• Develops and implements position-related tools, templates policies and procedure

• 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.

• Maintains up-to-date tracking of all contracts and client correspondence and provides periodic internal updates.

• Prepares ad hoc management reports as required.

• Leads or participates in client and team calls.

• Participate in contract review meetings.

Qualifications

Bachelor's degree (BS, BA) required, Business Administration or Legal Studies field preferred. Minimum of (5) years' clinical research experience required, one (1) to two (2) years' senior, lead or supervisory experience required. Experience with legal language (contracts, confidentiality agreements, etc. ) preferred. Advanced legal training/coursework preferred.

• Contract negotiation skill

• Knowledge of contract management principle

• 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 procedure

• Ability to effectively present information and respond to questions from managers and clients at all levels.

• Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exist

• Ability to work independently, supervise staff and work as part of a project team

• Highly organized with excellent oral and written communication skill

• Analytical skills, problem-solving skills and attention to detail

• Confident dealing with internal staff, and external stakeholders as required

• Full time presence in the office is required