Contracts Spec II, Site Agreement professional

ob Overview:

Prepares and negotiates and assists in the execution and retention of site agreements, confidentiality agreements, letters of indemnification and other contracts for Sponsors who contract Fortrea to perform this service. Maintains and contributes to contracts tracking and status systems and supports maintenance of paper and electronic file systems. Responsible for following SOPs including but not limited to departmental SOPs, as well as completing study-related duties in accordance with the processes set forth in the relevant process document. Primary contact with investigative site(s) during site maintenance activities with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor.

Summary of Responsibilities:

• Responsible for adherence to standard operating procedures (SOPs).
• Perform the following, with minimal guidance from line management or more experienced colleagues: daily tracking, negotiation and approval of Site Agreements and Site Agreement templates (as applicable) for clinical study teams; timely updating of the departmental Site Agreement Management System ( SAMS ) or any other system required for use on a particular study.
• Identify and escalate issues (as defined in departmental processes) that must be escalated to line manager for review.
• Complete submissions to and liaise with IRB/IEC/Third body/Regulatory Authority as applicable regarding submission/approval issues.
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
• Perform a review of final submission documents as applicable.
• Ensure appropriate systems are updated accurately and compliantly, ensuring others follow established processes.
• Confirm quality of tasks delegated to and completed by Contracts Associate.
• Manage assigned studies with careful compliance with internal processes and procedures, or otherwise according to specified Sponsor requirements.
• Responsible for the timely updating of the departmental contract tracking system.
• Performs contract administration functions including assisting with obtaining approvals on authorization forms as required; maintaining a contract tracking system to report contract status updates and signing status; providing notice of all executed contracts to the appropriate team members along with contract values; and scanning and filing executed contracts in the shared electronic storage area in a timely manner for access by other staff members.
• Support line manager with departmental goals, objectives, and initiatives in a positive and flexible way.
• Provides management with regular status updates on all open contracts and any outstanding issues.
• Proactively identifying, preventing and escalating to Submission Leads any risk to meeting deliverables.
• Notify the Submissions Lead of hours identified as Out-of-Scope or over burn.
• Complies with and fulfils corporate requirements of the position including, inputting activities in Timesheets, conducting all required training and documenting training in training systems, and preparing and submitting any company expense reports for reimbursement in a timely manner.
• Responsible for the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.
• Drafts, negotiates, reviews, and processes contracts in a commercially reasonably manner that protects Fortrea s fundamental interests and in accordance with departmental practices and policies. Produces and negotiates contracts that accurately reflect Fortrea s obligations or rights and understandings with third parties.
• Negotiates contractual terms with other contracting parties in a professional manner.
• Ability to apply knowledge of the principles of ICH GCP to their work and follow quality standard procedures.
• Identifies potential obstacles in the contracting process promptly and requests assistance of line manager, project management staff, Business Development staff, Budgets and Proposals staff or higher management as necessary to minimize delays and to facilitate the prompt conclusion of contractual negotiations.
• Works closely with appropriate staff to keep them informed of progress of agreements and to avoid any delays in execution.
• Provides support to other Site Agreements staff and assists internal staff with contractual inquiries as required.
• Facilitates the internal review/revision/sign off process on contracts prior to forwarding to external parties.
• Coordinate and communicate with clinical study teams in a timely manner regarding contract details and timelines, as well as contract status reporting to ensure quick approval of templates and contracts.
• Support line manager with departmental goals, objectives and initiatives in a positive and flexible way.
• Assist in development and ongoing improvement of departmental processes and procedures.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelor s degree (LLB, JD, BA or BS) preferred; university-level law degree preferred (UK/EU).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Minimum 2 - 4 years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

Physical Demands/Work Environment:

• 100% Office environment.

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