Senior Centralized Study Spec

Job description

- **Summary of Responsibilities:** - Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs), confidentiality agreements, amendments, and related site contract documentation. - Coordinate with sponsors, legal teams, clinical operations, and study teams to facilitate timely contract execution. - Manage site agreement timelines and ensure contracts are completed within study milestones and agreed turnaround timelines. - Maintain accurate contract status updates and documentation in SAMS, UCV, and other applicable systems. - Facilitate internal approval workflows and obtain required authorizations for agreement execution. - Track contract execution status and ensure executed documents are filed appropriately in shared repositories. - Identify contracting risks, delays, and issues proactively and escalate to management where required. - Provide regular updates to study teams and management regarding contract progress and outstanding issues. - Coordinate protocol amendment submissions and associated documentation updates for assigned studies and sites. - Support amendment-related contract and budget revisions in alignment with approved protocol changes. - Review amendment requirements and communicate action items, timelines, and documentation needs to sites and study teams. - Track amendment progress and ensure timely completion of submissions, approvals, and implementation activities. - Collaborate with cross-functional teams including Clinical Operations, Regulatory, Legal, and Finance to support amendment execution. - Ensure all amendment-related documents are uploaded and maintained accurately within applicable systems and trackers. - Support site communications and follow-up activities to address outstanding queries and prevent delays in amendment implementation. - Ensure adherence to SOPs, sponsor requirements, quality standards, and ICH-GCP principles. - Maintain accurate study trackers, reports, and metrics for contract and amendment activities. - Provide timely escalation of risks, delays, and operational challenges impacting study deliverables. - Support audit readiness by maintaining complete and accurate documentation. - Participate in process improvement initiatives and support departmental goals and objectives. - Collaborate effectively with internal and external stakeholders to ensure efficient study execution. - Complete assigned training, timesheets, and compliance-related activities within required timelines. **Required Skills & Competencies** - Strong understanding of clinical trial contracting and protocol amendment processes. - Knowledge of ICH-GCP guidelines and clinical research operations. - Excellent communication, negotiation, and stakeholder management skills. - Strong organizational and multitasking abilities with attention to detail. - Ability to manage multiple studies and priorities within tight timelines. - Proficiency in contract tracking systems and Microsoft Office applications. **Qualifications (Minimum Required):** - University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex. Nursing certification, Medical or laboratory technology). - 05-08years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Learn more about our EEO & Accommodations request here .