Clinical Research Associate I

Job Summary

Working remotely, the full-time Clinical Research Associate I will monitor clinical investigative sites to ensure adherence to protocols, conduct site visits for Phase 1-4 studies, and manage investigator payments while ensuring compliance with regulations and quality standards.

Key responsibilities:

• Monitor activities at clinical sites to ensure successful execution of study protocols and compliance with regulations
• Conduct site qualification, initiation, monitoring, and closeout visits in accordance with Good Clinical Practices and AbbVie SOPs
• Train site personnel on protocols and regulatory requirements while managing investigator agreements and payments

Required qualifications:

• Appropriate tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) preferred, with a Clinical Trials Master's Degree
• Minimum of 1 year of clinically-related experience, including 6 months in independent clinical research monitoring or as a Study Coordinator
• In-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations
• Strong planning and organizational skills to manage competing projects and deadlines effectively
• Ability to communicate clearly and address clinical site issues with appropriate guidance