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.