Research Analyst

• Participate in clinical research teams to ensure effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support
• Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods
• Communicate scientific rationale for assigned studies to team members and clinical sites
• Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
• Create/edit, distribute and collect site feasibility questionnaires
• Oversee and support collection of essential documents during study start-up
• Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution
• Collect study and site metrics and maintain study trackers
• Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
• Communicate regularly with field Clinical Research Associates to provide information before and after site visits
• Partner with field CRAs and CTAs to resolve issues identified during site visits
• Work with Supply Chain to ensure sites maintain sufficient investigational product and resolve IP temperature monitoring excursions and train or assist sites with corrective actions
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability
• Provide data listings and compile clinical study report documents to support medical writing activities
• Create and/or review of slides, overheads, etc., for project, departmental, sponsor and/or business development presentations
• Provide support and escalate issues to the Clinical Trial Manager as appropriate
• Performs other duties as assigned

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