Clinical quality assurance associate vs clinical research coordinator

Differences between clinical quality assurance associate and clinical research coordinator duties and responsibilities

Clinical quality assurance associate example responsibilities.

• Manage complex development programs consisting of multiple geographically separate teams supporting automation, regression, feature test and system test.
• Conduct audits for GCP, GLP and GMP facilities.
• Prepare internal study teams and provide support for FDA BIMO sponsor inspections.
• Assess compliance of Sponsor/Investigator/Monitor/Vendor activities to the study protocol, ICH GCP guidelines and all applicable regulations.
• Implement a full blown internet base CAPA system that allow internal and external customers to efficiently communicate need improvements.
• Assist in the resolution and approval for CAPA identify issues on sterilization and environmental microbial controls and implementing proactive programs.
Show more

Clinical research coordinator example responsibilities.

• Assess study participants for adverse reactions or complications and manage side effects of chemotherapy and other study relate drugs.
• Establish and maintain strong community partnerships to achieve HIV prevention objectives.
• Direct acquisition and analysis of functional MRI research data following GCP and FDA regulations
• Prepare and maintain IRB and regulatory documentation for various research projects and consent patients for clinical research.
• Facilitate constant communication between principal investigators, oncology nurses, and patients to address concerns and maximize eligibility and enrollment.
• Schedule patient for study procedures; initiate/coordinate drug orders, laboratory procedures and treatments for patients base on standing protocol orders.
Show more