Associate

• Support Phase 1, 2, 3, and 4 clinical studies with guidance
• Support study and site feasibility, start-up, maintenance, and close-out activities
• Manage study and site essential document review, collection, and tracking
• Support preparation and maintenance of study documents and manuals
• Provide oversight of the Trial Master File (TMF)
• Ensure study documents are received, reviewed, and filed in accordance with SOPs, GCP, and applicable regulations
• Organize study-related meetings, prepare agendas, take minutes, and maintain risk, issue, and decision logs
• Lead and present at study-related meetings as required
• Perform applicable site monitoring and co-monitoring visits
• Address internal and site quality assurance findings from audits
• Manage, coordinate, and oversee third-party vendor activities
• Perform study tracking and maintenance, including study status, enrollment, site queries, deviations, and study-level documents and plans
• Participate in clinical trial team meetings and collaborative efforts such as protocol development and CRO selection
• Support study site oversight, including site performance, metrics, and monitoring report review
• Support study data activities, including data review, query creation and resolution, deviation reviews, and safety reviews
• Work cross-functionally and provide oversight of CRO and vendor activities
• Review and verify contracted vendor activities, including vendor invoice review
• Support study reporting and tracking using applicable systems and technology
• Support study leads in cross-functional alignment of study timelines
• Complete required training, timesheets, expense reports, and CV updates
• Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements

Explore Global Study Associate – FSP at Parexel. Review requirements and application details.

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