Institutional research coordinator vs senior clinical research associate

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

Institutional research coordinator example responsibilities.

• Collect, manage and analyze preliminary data using SPSS statistical software.
• Answer phones, enter data into the computer using micrsoft excel, word, and powerpoint.
• Produce learning materials for workshops including PowerPoint presentations, group activities, program tools, and media delivery aids.
• Communicate with hospital physicians to educate them on the current NIH and FDA policies and guidelines regarding clinical research.
• Act as a liaison between the investigators and government agencies such as the FDA, DHHS, and OHRP.
• Participate in a sub-committee to provide comprehensive reports on all IRB activities to facilitate renewal of the AAHRPP accreditation
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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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