Clinical research associate vs project manager

Differences between clinical research associate and project manager 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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Project manager example responsibilities.

• Schedule and manage the GCP audit process.
• Define, develop and manage metrics and KPIs systems for new product business group.
• Manage the application process for the FDA medical device, minority and small business certifications.
• Manage multiple projects and resources simultaneously while mentoring, coaching and implementing best practices, SOX and HIPAA compliance standards.
• Lead teams using the Informatica ETL tool for the design and development of multiple financial and risk enterprise data warehouses.
• Administer and manage Salesforce requirements.
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