Medpace

Events

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;• Verification that the investigator is enrolling only eligible subjects;• Regulatory document review;• Medical device and/or investigational product/drug accountability and inventory;• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

CRC Event

• Write statistical programs for use in creating analysis datasets, tables, listings, and figures
• Review analysis plans for appropriate methods
• Program study analyses and review study results
• Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis

Statistics Event

• Write statistical programs for use in creating analysis datasets, tables, listings, and figures
• Review analysis plans for appropriate methods
• Program study analyses and review study results
• Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis
• Contribute to clinical development of plan preparation
• Review of study protocol and preparation of statistical methodologies
• Programming of study analysis, review of study results and preparation of statistical methods section for clinical / statistical reports
• Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis
• Communicate statistical results to medical writing personnel to ensure accurate interpretation
• Program edit checks for external data
• Integrate external data with the mapped database
• Coordinate communication with Data Manager, Biostatistician, and/or external database providers regarding database specifications and data transfers
• Implement edit check specifications via SAS programming to assist with reconciliation of data discrepancies
• Create annotated CRFs and mapping specifications per CDISC SDTM standards
• Create SDTM data via SAS programming by implementing data standards for collected study level source data

CRC Event

Statistics Event

Statistics Hiring Event