Job at a glance
Job Title: Clinical Research Associate Job Description The Clinical Research Associate performs and coordinates all aspects of clinical monitoring and site management for diverse clinical trials. This role conducts remote and on-site monitoring visits to assess protocol and regulatory compliance, manages essential documentation, and applies risk-based monitoring principles to ensure high-quality data and participant safety.
The Sr CRA I acts as a site process specialist, ensuring that each trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and standard operating procedures, while maintaining audit readiness and fostering strong collaborative relationships with investigational sites. Responsibilities Perform and coordinate all aspects of the clinical monitoring and site management process across multiple studies and sponsors.
Conduct remote and on-site monitoring visits using a risk-based monitoring approach to assess protocol adherence, regulatory compliance, and overall site performance. Apply root cause analysis, critical thinking, and problem-solving skills to identify site process failures and define corrective and preventive actions to bring sites into compliance and reduce risk. Ensure data accuracy and integrity through source data review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable, during on-site and remote monitoring activities.
Assess investigational product accountability through physical inventory checks and records review, confirming proper storage, handling, and documentation. Document monitoring observations clearly and comprehensively in reports and follow-up letters, using approved business writing standards and submitting them in a timely manner. Escalate observed deficiencies, non-compliance issues, and risks to clinical management promptly, and track all issues through to documented resolution.
Maintain regular communication with investigative sites between monitoring visits, as needed, to confirm protocol adherence, ensure timely data entry, and verify that previously identified issues are being resolved. Conduct all monitoring tasks in accordance with the approved monitoring plan and study-specific procedures. Participate in the investigator payment process, ensuring that payments are aligned with site performance and contractual terms.
Share responsibility with other project team members for resolving study issues and findings, collaborating to maintain study quality and timelines. Provide trial status tracking and progress updates to the Clinical Team Manager (CTM) or equivalent, as required. Update study systems, such as the Clinical Trial Management System (CTMS), according to agreed study conventions, ensuring that information is accurate and current.
Perform quality control checks of reports and outputs generated from CTMS or other systems, where required, to ensure completeness and accuracy. Participate in investigator meetings as needed, contributing to site training, protocol clarification, and study start-up activities. Identify potential investigators in collaboration with the sponsor to evaluate and recommend qualified investigative sites.
Initiate clinical trial sites according to relevant procedures, ensuring that each site is prepared, trained, and compliant with the protocol, ICH-GCP, and regulatory obligations. Ensure timely and compliant trial close-out at assigned sites, including retrieval of trial materials and verification that all essential documents and data are complete. Verify that required essential documents are complete, accurate, and appropriately filed in accordance with ICH-GCP and applicable regulations, including conducting on-site file reviews as per project specifications.
Contribute to project teams by assisting with the preparation of project tools and publications, such as monitoring tools, study newsletters, and other trial-related materials. Perform additional study-r