Clinical Research Associate

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
• Communicate with medical site staff including coordinators, clinical research physicians and their site staff.
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
• Verify medical record and research source documentation against case report form data; inform site staff of entry errors, ensure good documentation practices, and communicate protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
• Verify that the investigator is enrolling only eligible subjects.
• Review regulatory documents.
• Manage investigational product/drug accountability and inventory.
• Verify and review adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
• Assess the clinical research site’s patient recruitment and retention success and offer suggestions for improvement.
• Complete monitoring reports and follow-up letters, including summaries of significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

• Bachelor's degree in a health or science related field with at least 2–4 years of experience as a Clinical Research Associate.
• Proficient knowledge of Microsoft® Office.
• Outstanding communication skills; detail-oriented and efficient in time management.
• Demonstrated ability to independently function as a Lead CRA on more complex studies, including planning, delegating, and reviewing the work of others.
• Demonstrated ability to present at meetings and develop suggestions.
• Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external meetings.