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Trial Operations Specialist
hace 2 meses
CDS Fortrea Inc. is seeking a highly skilled Clinical Trial Coordinator to join our team. As a key member of our operations team, you will be responsible for ensuring the smooth execution of clinical trials.
Key Responsibilities- Serve as the primary point of contact for project teams and investigative sites, conducting site contacts and documenting interactions as required.
- Monitor site performance and implement action plans for sites that are not meeting expectations, in conjunction with the Clinical Research Associate (CRA).
- Assist CRAs with preparation for site visits, including running reports, quality checking files, and resolving action items from previous visits.
- Perform Case Report Form review, query generation, and resolution against established data review guidelines, under direct supervision on Covance or client data management systems.
- Coordinate study visits and shipments of drug, ancillary supplies, and laboratory kits/samples.
- Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- Liaise with project teams and others to distribute and track clinical trial supplies, ensuring sites have sufficient supplies to continue recruitment.
- Proactively work with sites and project teams to ensure maintenance activities, including amendments and revised documents, are completed for assigned sites as applicable.
- Demonstrate an understanding of the purpose and functionality of Clinical Trial Management Systems (CTMS) and navigate within different sections to enter weekly details or as per study requirements.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable.
- Facilitate translation and back-translation of necessary documents as required for local country regulations.
- Attend meetings, including investigator, sponsor, and kick-off meetings, and present at meetings as needed.
- Previous experience in logistics, imports, or supplies within a Contract Research Organization (CRO) environment.
- Completed job training in office management, administration, finance, or healthcare, or a Bachelor's Degree.
- Advanced English language skills.
- Strong IT skills, including Microsoft Office and Excel.
- Hands-on profile with a problem-solving and creative approach.
