Clinical Trial Coordinator

2 weeks ago

Carlsbad, United States Bolt Medical Full time
Job Title: Clinical Trial Assistant

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:
  • Ensure clinical trials are conducted in accordance with the protocol, standard operating procedures, ICH/GCP, and all applicable regulatory requirements.
  • Review and track progress of clinical trial, essential regulatory documentation from clinical sites before study start-up and throughout study conduct.
  • Collect and file all documents throughout the trial(s) and post-trial(s) activities.
  • Support TMF quality control and reconciliation.
  • Prepare study files for investigational sites and coordinate the development of associated documents and review them for completeness and accuracy.
  • Maintain trial, country, and site level protocol information in trial management systems.
  • Manage study data, budget, and payments, investigational products, mailings, and correspondence and other relevant tasks in support of the CPM and Sr. CRA.
  • Ensure current versions of the required trial documents, trial-related materials, and supplies are provided to the investigational site(s) within required timeframes.
  • Coordinate archiving of study relevant documents/files.
  • Ensure audit and inspection readiness.
  • Assist with user acceptance testing of eTMF and databases.
  • Assist in the development of case report forms and case report form completion guidelines (CCGs).
  • Provide process improvement suggestions if applicable.
  • Provide updates to study specific internal data repositories to ensure availability of trial documents to the study team.
  • Organize training for SIVs or small investigator meetings if requested.
  • Assist clinical operations project team with gathering agenda topics, preparing agenda, scheduling meetings, liaising with meeting planners, and coordinating logistics for internal or external meetings.
  • Attend, participate, prepare, and distribute meeting minutes and action items for both internal and external meetings.
  • Support preparations and response to audits, internal review, documentation, etc.
  • Review Site Visit Reports for accuracy, quality, and consistency.
  • Assist with managing study vendors.
Qualifications:
  • BA/BS degree in Life Sciences, Nursing, or related scientific field (or equivalent experience).
  • 1-2 years of relevant clinical trial experience with associated skill sets.
  • Previous experience in the pharmaceutical industry/biotech (biotech a plus).
  • Experience in Florence TMF is desirable.

Bolt Medical offers a hybrid work environment with a minimum of 3 days per week in our Carlsbad, California office. If you are a detail-oriented and organized individual with a passion for clinical trials, we encourage you to apply for this exciting opportunity.

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