Clinical Research Regulatory Coordinator

Job Summary

A company is looking for a Clinical Research Regulatory Coordinator II.

Key Responsibilities

• Facilitate initial new trial submissions for SRC and IRB review
• Develop the Informed Consent document with input from the trial's sponsor and Principal Investigator
• Maintain clinical trial regulatory documents and files during the IRB review process

Required Qualifications

• Bachelor's Degree in Healthcare Management or a related field required
• 2-3 years of Regulatory Affairs experience required
• Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations
• Understanding of the clinical trial process and regulatory compliance
• Proficiency in using relevant software for regulatory documentation management