Senior clinical research coordinator vs senior clinical research associate

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

Senior clinical research coordinator example responsibilities.

• Work closely with investigators in identifying and managing adverse events and report events according to FDA requirements.
• Mentore and train employees on proper ICH and GCP clinical study procedures.
• Leverage exceptional working knowledge of good clinical practice (GCP) and ICH regulatory instructions during the execution of clinical trials.
• Co-Authore informed consents and consent patients while conducting information sessions with potential study subjects.
• Authore study specific documents according to FDA regulations.
• Conduct internal audits of oncology therapeutic trials for quality assurance purposes.
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