Research Analyst

• Schedule and perform on-site or remote monitoring visit activities, inclusive of the following study visit types: Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) / Routine Monitoring Visit (RMV), and Close Out Visit (COV).
• Contribute to the development of protocols, study tools, materials, and documentation for clinical sites.
• Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed.
• Review site-level investigational drug accountability and safety event documentation.
• Review and verify patient files and records, informed consent, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies; provide training and/or initiate corrective action as required.
• Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan.
• Manage query resolution.
• Provide mentoring, training, and co-monitoring of junior team members.
• Assist in the development of applicable WEP Clinical Standard Operating Procedures.
• Develop applicable document templates, including (but not limited to), Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs.
• Complete, review, and/or submit monitoring reports and query logs.
• Address protocol or monitoring-related questions received from clinical sites for assigned programs.

Clinical Research Associate

• Collect and analyze data and develop decision support software, services, or products.
• Develop and supply optimal time, cost, or logistics networks for program evaluation, review, or implementation.

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Clinical Research Associate

Operations Research Analyst