Research project coordinator vs senior clinical research associate

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

Research project coordinator example responsibilities.

• Manage study documentation throughout study life cycle including IRB annual renewals, modifications, patient study charts and regulatory binder.
• Recommend administrative revisions to IRB submit studies including inform consent documents.
• Demonstrate small molecule are protective against DNA damage in mouse model of melanoma.
• Conduct analysis using SPSS which result in developing a new software for students to selecting college.
• Conduct primary research through interviews with Boston area travelers and analyze raw data into reports via SPSS.
• Maintain FDA correspondence and government documentation.
Show more

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.
Show more