Senior research coordinator vs senior clinical research associate

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

Senior research coordinator example responsibilities.

• Perform insightful data analyses and adequately manage IRB protocol.
• Collect, manage and analyze preliminary data using SPSS statistical software.
• Coordinate patient screening and intake as well as educated patients about inform consent and drug accountability.
• Create and present PowerPoint slides for training webinars, meetings, and conferences.
• Oversee research program and ensure all elements of the program are in compliance with FDA regulations.
• Create a process for FDA hold import shipments, in order so items will not be used.
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Senior clinical research associate example responsibilities.

• Manage a consultant to review scientific support and create dossiers on each product that make health claims in the EU.
• Interact with FDA and other regulatory authorities to manage and facilitate approval of regulatory submissions.
• Monitor U.S. sites in accordance with ICH and GCP guidelines.
• Maintain investigators and subjects files, review investigators files for compliance with GCP and FDA regulations, review drug utilization records.
• Verify informed consent procedures and protocol requirements base on applicable regulatory requirements to ensure protection of study patients.
• Provide site management for both therapeutic and supportive care oncology protocols that are complex and require knowledge in advance therapeutic areas.
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