Trial Master File Specialist/Clinical Trial Assistant

Location
Newark, CA
Posted
Aug 25, 2020
Ref
Trial Master File Specialist/Clinical Trial Assist
Required Education
Bachelors Degree
Position Type
Full time

PRIMARY RESPONSIBILITY

The Trial Master File Specialist/Clinical Trial Assistant is responsible for administration, maintenance and coordination of the logistical aspects of the company’s clinical trials according to Good Clinical Practice and relevant SOPs.  This role will provide subject matter expertise and Clinical Operations Team support required to ensure that the Trial Master File is inspection ready for all studies conducted by InCarda Therapeutics.  This role is also responsible for being pivotal point of contact for the Clinical Operations team and any Contract Research Organizations (CROs) used. This position requires a minimum of 2 years of experience in the pharmaceutical/clinical research environment with at least 1 year of CTA or Trial Master File Specialist experience.

Key Accountabilities/Core Job Responsibilities:

  • Facilitate the creation of study specific TMF management tools
  • Maintain TMF Management Plans and TMF Content Lists; work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level 
  • Coordinate creation of the TMF filing locations within InCarda based on the study specific TMF Content List 
  • Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF 
  • Facilitate the review and submission of TMF records 
  • Support the coordination of the transfer of study-specific trial master files from the CRO 
  • Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
  • Support Study Teams in understanding their TMF-related responsibilities, requirements and expectations
  • Act as point person for Study Team TMF questions and manage close-out of TMF related issues in adherence to InCarda processes 
  • Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
  • Manage the TMF content list and TMF Comprehensive Review tracker 
  • Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by management 
  • Participate in the conduct of quality review of the TMF for each assigned study on an annual basis per the time points captured in the study specific TMF Plan
  • Identify any corrective actions which must be addressed and assigned 
  • Support the management of TMF documentation issues throughout the lifecycle of an assigned study Records Management 
  • Participate in the implementation of standards and processes for records management to verify compliance with relevant regulations 
  • Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records
  • Process records (e.g., track, scan, archive) in compliance with InCarda SOPs and study specific TMF Plans
  • Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records 
  • Provide guidance on best practices for record handling, retrieval and archival procedures
  • Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits 
  • Participate in the development, implementation, and maintenance of internal databases used to manage records 
  • Assist in the preparation of project and study-related documents including informed consent forms, pharmacy manual, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries, as required
  • Assist with coordination of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IV(W)RS specification process and user acceptance testing
  • Assist in monitoring and tracking clinical trial progress and providing status update reports and study metrics
  • Assist in the planning of investigator meetings and making presentations, as required. 
  • Prepare meeting agendas and minutes
  • Facilitate communications on behalf of the Study Team to include correspondence, mass mailings, email communications, etc. Assist in the review of clinical data in the CRF, data listing, and report table levels
  • Perform other duties as assigned 

Qualifications:

  • Good organization and planning skills
  • Strong interpersonal skills and communication skills (both written and oral)
  • Ability to problem-solve
  • Excellent comprehension of Good Clinical Practices and basic concepts of clinical research

Experience:

  • This position requires a minimum of 2 years of experience in the pharmaceutical/clinical research environment with at least 1 year of CTA or Trial Master File Specialist experience.