Clinical Trial Coordinator

2 months ago


Carlsbad, United States Bolt Medical Full time
Job Summary

Bolt Medical is seeking a highly organized and detail-oriented Clinical Trial Assistant to join our team. As a Clinical Trial Assistant, you will play a critical role in the success of our clinical trials by assisting with the review, tracking, and monitoring of day-to-day aspects of clinical trials at investigative sites.

Key Responsibilities
  • Protocol Compliance: Ensure clinical trials are conducted in accordance with the protocol, standard operating procedures, ICH/GCP, and all applicable regulatory requirements.
  • Document Management: Collect, record, and file clinical trial documentation, including financial disclosures, debarment checks, current CVs, GCPs, and relevant certification and licensing requirements.
  • Site Support: Prepare study files for investigational sites, coordinate the development of associated documents, and review them for completeness and accuracy.
  • Trial Management: Maintain trial, country, and site level protocol information in trial management systems, manage study data, budget, and payments, and ensure current versions of required trial documents and trial-related materials are provided to investigational sites.
  • Audit and Inspection Readiness: Ensure audit and inspection readiness by coordinating archiving of study relevant documents/files and providing updates to study specific internal data repositories.
  • Process Improvement: Provide process improvement suggestions and assist with user acceptance testing of eTMF and databases.
Requirements
  • Education: BA/BS degree in Life Sciences, Nursing, or related scientific field (or equivalent experience).
  • Experience: 1-2 years of relevant clinical trial experience with associated skill sets, previous experience in the pharmaceutical industry/biotech, and experience in Florence TMF is desirable.
  • Skills: Proficient in English language (spoken and written), strong knowledge of MS Office (Word, Excel, Outlook, and PowerPoint), and Adobe Acrobat, strong interpersonal skills, excellent organizational skills, and ability to collaborate and handle multiple priorities within a matrix environment.


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