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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