Job 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.
Summary of Responsibilities:
- Negotiate directly with assigned sites on all site related contracting items including clinical trial agreements, budgets, payment terms, ancillary agreements and amendments.
- 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.
- Manage assigned studies 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.
- 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.
- Drafts, negotiates, reviews, and processes contracts in accordance with departmental practices and policies.
- 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.
- 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;
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.
- Ability to explain data to facilitate decision making processes to be data driven.
- Knowledge and understanding of clinical study protocols and schedule of assessments.
- Strong organizational skills, decision making, communication and negotiation skills.
- Effective communication skills
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Strong proficiency with Microsoft Office applications
- Fluent business English (oral and written)
Learn more about our EEO & Accommodations request here.
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