REGULATORY AND START-UP

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). • 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.