Clinical Trial Master File Specialist

New
  • Location
    Irvine, California
  • Job type
    Contract/Temporary
  • Category
    Medical & Science - Pharmaceutical - Clinical


Adecco Medical and Science has an immediate need for multiple Clinical Trial Master File Specialists for our Orange County, CA location. The succesful candidates MUST HAVE previous experience with TMF Reference Model to maintain and manage essential documents, working knowledge of Clinical Trial Management Systems (CTMS) and eTMF Management system experience preferbly with (Veeva, Rave, etc.)

Job Summary:


The Trial Master File Specialist provides support to the clinical study teams in the execution of clinical trials. Primary responsibilities include maintaining Trial Master File (TMF) in an inspection-ready state, assisting with site management, initiating collection, reviewing and tracking of essential documents throughout the life of the trial. Contributes to the production and distribution of study materials and site/study communications.

Essential Duties and Responsibilities:


· Establishes and maintains essential documents within the TMF (according to the TMF
Reference Model)
· Reviews the TMF for compliance, addressing findings as needed and supporting the study
team with study activities
· Assists in the development, handling, distribution, review, filing and archiving of essential
documents in the TMF
· Assist project teams with the creation and maintenance of study specific documentation
· Handles incoming and outgoing clinical trial related materials shipments to site, study
team, CRAs and vendors, as needed
· Assists with all aspects of initial study product/device release including regulatory packet
review, creation of investigator site file and study-device shipment
· Communicates directly with sites and CRAs to obtain updated information, essential
documents, etc. to assist with driving start-up, study conduct, and/or close out activities
· Participates in clinical team meetings, including attending required meetings & generates
meeting agenda, minutes and action items
· Maintains completion log of required corporate training on standards, policies, work
instructions by due date
· Identifies and escalates issues appropriately
· Coordinates and maintains ordering, communication and tracking of trial materials (e.g.
CRFs, lab supplies, device supplies) as appropriate
· Create, manage & track shipment of investigational product/device and collect and file
appropriate documentation
· Identify areas for process & technology improvement
· Performs other work-related duties as assigned

Education and Experience:


· 1-3 years of work experience in a Clinical Research setting required, Bachelor’s Degree in
Life Sciences or Social Sciences preferred
· Knowledge of clinical research procedures and regulatory requirements including following SOPs, FDA regulations and ICH GCP guidelines
· Ability to work in a team environment
· Ability to maintain positive relationships both internally and externally
· Understanding relevant clinical operations activities
· Experience assisting in preparation and management of study specific documents
· Excellent computer skills with proficiency in Microsoft Office programs (e.g., Microsoft
Word, Excel, PowerPoint, Outlook)
· Working knowledge of TMF Reference Model to maintain and manage essential documents
· Effective time management and organization skills & attention to detail and accuracy in
work
· Ability to multi-task under limited direction and on own initiative
· Working knowledge of Clinical Trial Management Systems (CTMS)
· eTMF Management system experience strongly preferred (Veeva, Rave, etc.)


If you are interested in these Clinical Trial Master File Specialist jobs in Orance County, CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com. If you have questions about the position or would like more information please contact Randy Williamson at 858-812-2601 or by email at randy.williamson@adeccona.com.

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Reference number US_EN_2_108175_330607