REGULATORY AND START-UP
Summary of Responsibilities
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Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs), confidentiality agreements, amendments, and related site contract documentation.
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Coordinate with sponsors, legal teams, clinical operations, and study teams to facilitate timely contract execution.
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Manage site agreement timelines and ensure contracts are completed within study milestones and agreed turnaround timelines.
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Maintain accurate contract status updates and documentation in SAMS, UCV, and other applicable systems.
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Facilitate internal approval workflows and obtain required authorizations for agreement execution.
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Track contract execution status and ensure executed documents are filed appropriately in shared repositories.
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Identify contracting risks, delays, and issues proactively and escalate to management where required.
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Provide regular updates to study teams and management regarding contract progress and outstanding issues.
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Coordinate protocol amendment submissions and associated documentation updates for assigned studies and sites.
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Support amendment-related contract and budget revisions in alignment with approved protocol changes.
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Review amendment requirements and communicate action items, timelines, and documentation needs to sites and study teams.
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Track amendment progress and ensure timely completion of submissions, approvals, and implementation activities.
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Collaborate with cross-functional teams including Clinical Operations, Regulatory, Legal, and Finance to support amendment execution.
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Ensure all amendment-related documents are uploaded and maintained accurately within applicable systems and trackers.
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Support site communications and follow-up activities to address outstanding queries and prevent delays in amendment implementation.
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Ensure adherence to SOPs, sponsor requirements, quality standards, and ICH-GCP principles.
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Maintain accurate study trackers, reports, and metrics for contract and amendment activities.
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Provide timely escalation of risks, delays, and operational challenges impacting study deliverables.
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Support audit readiness by maintaining complete and accurate documentation.
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Participate in process improvement initiatives and support departmental goals and objectives.
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Collaborate effectively with internal and external stakeholders to ensure efficient study execution.
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Complete assigned training, timesheets, and compliance-related activities within required timelines.
Required Skills & Competencies
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Strong understanding of clinical trial contracting and protocol amendment processes.
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Knowledge of ICH-GCP guidelines and clinical research operations.
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Excellent communication, negotiation, and stakeholder management skills.
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Strong organizational and multitasking abilities with attention to detail.
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Ability to manage multiple studies and priorities within tight timelines.
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Proficiency in contract tracking systems and Microsoft Office applications.
Qualifications (Minimum Required)
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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).
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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.
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Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
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03-05 Years of experience in the job discipline.
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00-02 Years of experience in other professional roles.
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Other required work-related experiences
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Demonstrated ability to organize and communicate effectively.
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Demonstrated ability to pay attention to detail.
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Ability to work well with others.
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Ability to deliver consistent high quality of work.
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Ability to use computer and departmental tools.
Physical Demands/Work Environment
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General Office Environment.
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