Sr CRA

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.

• 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…