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
• Collect study and site metrics and maintain study trackers
• Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed
• Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits
• Partner with field CRAs to resolve issues identified during site visits
• Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) 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
• Clinical specimen log review and coordinating shipment of specimens to the sponsor or contracted vendor
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability
• Provide mentorship and training to newly hired research staff
• Perform other duties as assigned

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