inSeption GroupSr. Clinical Research Associate - Hematology/Oncology/CAR T / Regional Site Mgr.
Mar. 2023Chicago, Illinois, United States• Managing key deliverables for inSeption Group and their stakeholders, including study activities, timelines, and schedules on the country level. • Serving as Lead CRA while managing groups of 2-5 co-monitors, including scheduling, organization of workload, compilation of findings, and execution of trip reports.
• Overseeing management, communication, and integrity of the study at assigned sites; serving as a key liaison for the study sponsor and team by fostering excellent relationships with site PI and staff. • Actively ensuring the rights, safety, and well-being of patients in accordance with the study protocol and ICH-GCP requirements.
• Executing hands-on activities from study concept to study closeout, including: - Site Identification, Qualification, and Selection - Site Start-Up Essential Document Review and Approval (ICH-GCP Guidelines) - Site Initiation, Training, and Activation - Site Screening and Enrollment - Interim Monitoring & Regulatory Review – Remote and Onsite visits. - Site Closeout • Proactively managing the collection and reporting of quality and timely data collection, query resolution, reporting of protocol deviations, and SAEs/AESIs. Escalating any issues, as appropriate.
• Monitoring of eCRFs, source data, and query resolution. Ensuring completion and reconciliation of the Investigator Site File and Trial Master File. Comprehensive recording of visit findings via written reports.
• Tracking Biologic samples, as well as managing receipt, storage, handling, dispensing, resupply, and destruction of all site supplies, as needed. • Generating and analyzing site metrics reports; identifying and reporting any trends identified.
• Implementing all written plans provided by the study team toward the management of the sites.
• Serving as a trainer and mentor for junior staff.