Clinical Research Associate II Cancer Center Protocol Office

1 month ago

Boston, United States Mass General Brigham Full time

Description: GENERAL SUMMARY/ OVERVIEW STATEMENT: The Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking Clinical Research Associate (CRA) candidates to assist with the coordination and monitoring of multiple oncology trials. The multi-center CRA works under general supervision to maintain regulatory files and monitor data quality and data and protocol compliance across participating study sites. The CRA will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of regulatory document coordination and tracking and clinical data review. This position does not include any direct patient contact. PRINCIPAL DUTIES AND RESPONSIBILITIES: The CRA will perform the following duties under general supervision by the Clinical Research Manager: Track the progress of the trial across all participating sites (e.g., accrual, biospecimen collection and transfer, reportable events, regulatory submissions) Correspond with participating sites to support trial activities as needed: Answer questions about eligibility, study procedures or data entry Prepare and distribute informational updates, including meeting minutes, missing data reports and safety reports Communicate essential trial information and documentation, including protocol amendments; request routine updates from sites to maintain current study status Facilitate database reviews and query resolution · Present the Sponsor-Investigator study status reports related to trial progress and assigned tasks Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria Conduct onsite and remote monitoring visits and complete corresponding monitoring reports (Domestic travel required for onsite monitoring

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