Clinical Research Associate

Role Overview and Responsibilities

The Clinical Research Associate will manage key site visits including qualification, initiation, monitoring, and closeout to ensure adherence to approved study protocols. This role involves close collaboration with site personnel such as coordinators and clinical research physicians, ensuring all research activities align with guidelines and regulations.

• Perform comprehensive qualification and monitoring visits across research sites to verify protocol compliance.
• Maintain active communication with medical site staff, including coordinators and physicians, to support study execution.
• Confirm investigators possess necessary qualifications, training, and resources, encompassing facilities, labs, equipment, and staff availability.
• Verify medical records and source documentation against case report forms to detect discrepancies, reinforce proper documentation, and flag protocol deviations following SOPs, GCP, and regulatory standards.
• Ensure enrollment strictly includes eligible subjects in line with study criteria.
• Review regulatory documents for completeness and compliance.
• Manage investigational product accountability and inventory processes reliably.
• Evaluate adverse events, serious adverse events, concomitant medications, and related conditions to ensure accurate data reporting as per protocol requirements.
• Assess patient recruitment and retention at clinical research sites and propose strategies for enhancement.
• Prepare detailed monitoring reports and follow-up communications summarizing key findings, deviations, deficiencies, and recommended corrective measures to maintain compliance.

Essential Qualifications

• A bachelor's degree in health sciences or a related scientific field is required.
• At least one year of experience as a study coordinator or clinical research coordinator is preferred.
• Familiarity with clinical monitoring practices and procedures to effectively represent the function during internal and external meetings, including business development discussions.