Clinical research associate vs regulatory affairs specialist

Differences between clinical research associate and regulatory affairs specialist 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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Regulatory affairs specialist example responsibilities.

• Gather, evaluating, organizing, managing and collating information in a variety of formats.
• Manage CRO (regulatory) in support of the company's approve product in Europe.
• Manage and submit electronic EPA product registrations.
• Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
• Support complaint handling process and screening, ensure FDA 21 CFR compliance.
• Close complaints receive from external customers in compliance with FDA, ISO, QSR and other regulatory guidelines.
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