Centralized Study Spec II

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.

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