- Bachelor’s degree in life sciences, nursing, or a related field.
- 1 year of experience in clinical research or a related field.
- Knowledge of GCP, ICH guidelines, and regulatory requirements.
- Strong organizational and time management skills.
- Excellent communication and interpersonal skills.
- Proficiency in Microsoft Office Suite
A large medical device company located in Irvine, CA is looking for a Clinical Study Associate to support the planning, executing, and management of clinical trials. The responsibilities will include but are not limited to:
- Assist in the preparation and review of study-related documents, including protocols, consent forms, and reports
- Coordinate and manage logistics for clinical trials
- Ensure accurate and timely data collection, entry, and reporting.
- Monitor study progress and maintain study timelines.
- Communicate effectively with study sites and internal teams to resolve issues and ensure smooth study conduct.
- Assist in the preparation of regulatory submissions and responses to regulatory agencies.
- Maintain study files and documentation in accordance with Good Clinical Practice (GCP) and company SOPs.
- Participate in team meetings and provide updates on study status