Clinical Trial Coordinator
2 weeks ago
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.
- 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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Clinical Trial Coordinator
1 month ago
Carlsbad, United States Bolt Medical Full timeJob SummaryBolt 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...
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Clinical Trial Coordinator
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Carlsbad, CA, USA, United States Bolt Medical Full timeJob Title: Clinical Trial AssistantBolt 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 day-to-day aspects of clinical trials, ensuring that all documentation is collected, recorded, and filed in accordance with regulatory requirements.Key...
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