CRA (Level I)

Job description preview

From Thermo Fisher Scientific’s original posting

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The CRA Level I performs and coordinates different aspects of the clinical monitoring and site management process. The role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. The CRA manages procedures and guidelines across different sponsors and/or monitoring environments, including FSO, FSP, and Government environments. The CRA acts as a site processes specialist, ensuring clinical trials are conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, with the objective of protecting subjects' rights and well-being and ensuring data reliability and audit readiness. The role also develops collaborative relationships with investigational sites. Key Responsibilities Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving to identify process failures and implement corrective/preventive actions. Ensure data accuracy through SDR, SDV, and CRF review, as applicable, through on-site and remote monitoring. Assess investigational…