Clinical Research Site Monitor

The Clinical Site Monitor is responsible for overseeing and managing clinical trial sites to ensure compliance with regulatory requirements, study protocols, and Good Clinical Practice (GCP). This role involves regular site visits, data verification, and communication with site personnel to ensure that clinical trials are conducted efficiently and effectively.

Qualifications

• Bachelor\’s degree in life science/related field, advanced degree preferred
• Minimum of 3+ years in clinical research industry
• Solid understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA), and clinical trial processes.
• Previous experience as a clinical research associate/ assistant, preferably in hepatology
• Excellent organizational, communication, and interpersonal skills.
• Ability to manage multiple priorities and work effectively in a team environment.
• Work well under pressure ensuring tasks are prioritized and goals are met.
• Willingness to travel frequently to clinical trial sites.

Responsibilities

• Conduct regular site visits to monitor study progress, verify adherence to study protocols, and ensure proper documentation.
• Assess site performance and identify any issues or risks that may impact the integrity of the trial.
• Provide training and guidance to site staff on study protocols, procedures, and regulatory requirements.
• Review and verify source data against case report forms (CRFs) and other study documentation to ensure accuracy and completeness.
• Identify and resolve discrepancies or issues in data collection and reporting.
• Ensure that clinical trials are conducted in compliance with regulatory requirements, including FDA guidelines, ICH GCP, and local regulations.
• Perform audits and inspections to assess site adherence to study protocols and GCP standards.
• Address and resolve any compliance issues or non-conformances.
• Serve as the primary point of contact between the sponsor and the clinical site.
• Provide regular updates and reports on site performance, progress, and any issues to the study team and sponsor.
• Facilitate communication and collaboration between site staff, investigators, and the study team.
• Ensure that all study-related documents are accurate, complete, and up-to-date.
• Maintain thorough and organized records of monitoring activities, site correspondence, and study data.
• Identify potential issues or risks related to study conduct and develop strategies to address them.
• Provide solutions and recommendations to enhance site performance and trial outcomes.

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