Clinical research associate vs clinical trials associate

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

Clinical research associate example responsibilities.

• Manage, schedule and train up to 15 CRAs.
• Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
• Manage site TMF to ensure communication requirements adherence
• Manage CRO and regional monitor to complete close out activities, including device accountability management.
• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.
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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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