Clinical Research Coordinator

2 days ago


Irvine, United States Insight Global Full time

Location: HYBRID- Tuesday and Thursdays ( every other Friday) In office




Contract Duration: 1 year with possible extensions




MUST HAVES:

  • 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



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