Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and clinical development excellence. We offer pharmaceutical, biotechnology, and medical device clients a diverse range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.
The Clinical Operations Coordinator will support day-to-day operational tasks and assist in ensuring the quality and productivity of clinical studies. This role involves managing clinical systems, maintaining study documents, and supporting the study team in various capacities.
Standard Operating Procedures: Follow all applicable departmental Standard Operating Procedures (SOPs) and Work Instructions.
Daily Operations: Complete day-to-day tasks ensuring quality and productivity.
Metrics Tracking: Track and report metrics as determined by management according to required timelines.
Process Improvement: Participate in process improvement initiatives and assist with implementing revised processes and procedures.
Study Management Support:
Documentation and Compliance: Document and track study activities using relevant forms and tools. Maintain Trial Master File (TMF) documentation within the appropriate TMF platform, participate in TMF QC as assigned, and track/archive documents as applicable.
Project Health Monitoring: Actively support compliance metrics, including TMF, CTMS, and overall project health. Update timelines and milestones within project scheduling tools, CTMS, and other trackers, escalating any risks to timelines.
Risk Management: Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up on outstanding action items to resolution, including protocol deviations.
Project Planning: Draft or assist Functional Leads with project plans, coordinating review, feedback, and execution between the study team and client.
Team Collaboration: Facilitate study team communication and collaboration by organizing team meetings and documenting discussions, ensuring compliance with study requirements.
Vendor Management: Provide oversight for vendor management activities.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment to revolutionizing the development process ensures the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative workspace that nurtures personal growth and enables you to make a meaningful global impact.
Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, gender, sexual orientation, age, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
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