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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