Clinical research coordinator vs senior clinical research associate

Differences between clinical research coordinator and senior clinical research associate duties and responsibilities

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.
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Senior clinical research associate example responsibilities.

• Manage a consultant to review scientific support and create dossiers on each product that make health claims in the EU.
• Interact with FDA and other regulatory authorities to manage and facilitate approval of regulatory submissions.
• Monitor U.S. sites in accordance with ICH and GCP guidelines.
• Maintain investigators and subjects files, review investigators files for compliance with GCP and FDA regulations, review drug utilization records.
• Verify informed consent procedures and protocol requirements base on applicable regulatory requirements to ensure protection of study patients.
• Provide site management for both therapeutic and supportive care oncology protocols that are complex and require knowledge in advance therapeutic areas.
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