Clinical trials associate vs clinical research coordinator

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

Clinical trials associate example responsibilities.

• Manage trial master files and study document to meet GCP/ICH and internal guidelines for records retention.
• Audit TMF to ensure all require regulatory documentation are collected and lead.
• Work closely with investigators to recruit eligible patients to clinical protocols, manage data collection and preparation.
• Preform ICF customization in accordance with ICH guidelines, GCP s and local regulatory requirements.
• Support the setup, data entry and QC of the system to ensure accuracy and quality of data.
• Monitor clinical data and resolve inconsistencies according to FDA regulations and ICF guidelines.
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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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