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.

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