Clinical Research Associate

Role Overview

As a Clinical Research Associate, you will oversee and conduct qualification, initiation, monitoring, and closeout visits at research sites, ensuring adherence to approved study protocols and regulatory standards.

Key Responsibilities

• Perform site qualification, initiation, monitoring, and closeout visits in line with approved protocols.
• Liaise effectively with medical site personnel, including coordinators and clinical research physicians.
• Confirm investigator qualifications, training, and resource availability such as facilities, labs, equipment, and staff.
• Verify medical records and source documentation against case report forms, identify documentation errors, enforce good documentation practices, and report protocol deviations per SOPs, GCP, and regulatory guidelines.
• Ensure patient eligibility criteria are strictly followed for subject enrollment.
• Review regulatory documents thoroughly.
• Manage accountability and inventory of investigational products or drugs.
• Evaluate and review adverse events, serious adverse events, concomitant medications, and illnesses to guarantee accurate data submission per protocol.
• Assess patient recruitment and retention at clinical sites and propose improvement strategies.
• Prepare monitoring reports and follow-up letters outlining key findings, deviations, deficiencies, and recommended remedial actions to maintain compliance.

Required Qualifications and Skills

• Bachelor's degree in health or science-related discipline.
• Preferred minimum one year of experience as a study coordinator.
• Availability to travel approximately 60-80% nationwide or less if virtual/remote monitoring is possible.
• Excellent communication and presentation capabilities.
• Strong attention to detail and effective time management skills.