Regulatory and Start-Up

**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). * 03-05 years 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. **Experience (Minimum Required):** * 03-05 Years of experience in the job discipline. * 00-02 Years of experience in other professional roles. * **Other required work-related experiences:** * Demonstrated ability to organize and communicate effectively. * Demonstrated ability to pay attention to detail. * Ability to work well with others. * Ability to deliver consistent high quality of work. * Ability to use computer and departmental tools. **Physical Demands/Work Environment:** * General Office Environment. Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).