Clinical Trial Assistant

5 days ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.


Position Overview: The Clinical Trial Assistant will assist with the review, tracking and monitoring the day-to-day aspects of clinical trials at investigative sites and ensure clinical trial(s) documentation is collected, recorded, and filed. Ensure clinical trials are conducted in accordance with the protocol, standard operating procedures, ICH/GCP, and all applicable regulatory requirements.

Responsibilities:

  • Will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
  • Complies with relevant training requirements.
  • Review and tracks progress of clinical trial, essential regulatory documentation from clinical sites before study start-up and throughout study conduct, such as financial disclosures, debarment checks, current CVs, GCPs, relevant certification and licensing requirements. Collect and file all documents throughout the trial(s) and post-trial(s) activities. Support TMF quality control and reconciliation.
  • Collect and prepare documents required for study, such as start-up/submission to the IEC/IRB, in support of the CPM/Sr. CRA where applicable.
  • 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.
  • Manages 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.
  • Device Accountability of IP: partner with the Field team for IP shipment and transfers. Ensure accountability records are accurate from receipt through final disposition
  • 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.
  • If requested, organize training for SIVs or small investigator meetings.
  • Assist clinical operations project team with gathering agenda topics, preparing agenda, scheduling meetings. Liaise with meeting planners, and coordinate 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.

Qualification:

Education:

  • BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).

Required 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.

Knowledge, Skills, and Abilities:

  • 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 the ability to collaborate and handle multiple priorities within a matrix environment.
  • Perform activities in a timely and accurate manner.
  • Strong attention to detail is a must.
  • Able to work in a fast-paced, evolving biotech environment with focus on quality.
  • Works well with others and understands that collaboration leads to better results.

Location

Hybrid: Onsite- Carlsbad, California Office at least 3 days per week.

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