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Centralized Study Analyst

icon building Company : Fortrea
icon briefcase Job Type : Full Time

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Job Description - Centralized Study Analyst

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.

Learn more about our EEO & Accommodations request here.

Original job Centralized Study Analyst posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
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