Clinical research coordinator vs clinical trial manager

Differences between clinical research coordinator and clinical trial manager 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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Clinical trial manager example responsibilities.

• Manage SAEs and assure they are properly record and report.
• Manage CRO vendors and ensure timely execution of study milestones.
• Manage assign independent consultants and employee CRAs regarding project-relate issues.
• Lead study data management activities for oncology trials in preparation for study close-out.
• Ensure study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP and ICH guidelines.
• Create document templates require by FDA and ICH regulations for site distribution.
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