Clinical trials specialist vs clinical research coordinator

Differences between clinical trials specialist and clinical research coordinator duties and responsibilities

Clinical trials specialist example responsibilities.

• Manage all clinical data and subject source documentation through the EDC system to verify compliance and subject eligibility.
• Lead study data management activities for oncology trials in preparation for study close-out.
• Review clinical study documents for completeness and compliance with protocol, FDA regulations, ICH and GCP guidelines.
• Perform routine quality control (QC) of TMF and submit documents to ensure overall quality.
• Review ICF and study reports and find discrepancies that are missed by CRO management.
• Collect, review, approve and track in CTMS regulatory essential start-up and amendment documents.
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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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