Study Start Up Associate

Job Summary

Leading the initiation of clinical trials, the full-time Study Start Up Associate II will manage the preparation and submission of regulatory documents, coordinate with stakeholders for necessary approvals, and maintain accurate records of submissions, all while working remotely in the United States.

Key responsibilities

• Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
• Coordinate with internal and external stakeholders to obtain approvals for study initiation
• Provide guidance on regulatory requirements and participate in process improvement initiatives

Required qualifications

• 1+ years of clinical research experience in regulatory affairs, clinical research coordination, or study start-up activities
• Experience at a clinical research site is preferred
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP
• Bachelor's degree in life sciences, healthcare, or a related field
• Excellent organizational and project management skills