RHO

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TMF Specialist

TMF Specialist

ID 
2017-1361
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The TMF Specialist contributes to the success of the TMF business process and supports study teams as a contributing member in the role of TMF Specialist. The TMF Specialist is responsible for supporting process and system development to support and maintain high quality and compliant Trial Master Files (TMFs). The TMF Specialist provides expertise and guidance across study teams, functions and vendor partners. TMF Specialist reviews and approves or identifies issues with TMF content using a specific workflow and following relevant guidance. This position will participate as a study team member and will collaborate with functional SMEs to address consistent quality gaps. This position will also mentor In-House CRAs and Research Associates as well as provide oversight on milestones as they relate to TMF management. The TMF Specialist must be familiar with "second review" and authorization for site approval/IP Release.

Responsibilities

  • Support cross-functional efforts toward standardizing processes and maintaining compliance
  • Support develop and deliver training on all things eTMF
  • Promote inspection-ready TMFs in timeframe established by process and study specific requirements.
  • Accountable for ensuring quality TMFs in accordance with Rho SOPs. This requires daily QC activity and ongoing reviews to ensure compliance and inspection readiness at all times, including confirming that the content collectively provides an accurate reconstruction of the trial
  • Assist project team in preparation for internal/external audits
  • Attend study team meetings and complete relevant study specific training for assigned studies
  • Maintain a thorough understanding of study management tasks and responsibilities necessary for ensuring compliance with protocol and regulatory requirements
  • Liaise with study team as they secure Site Essential Documents, confidentiality agreements, master service agreements, clinical trial agreements as appropriate and prioritize sites for IP Release
  • Collaborate with PL and LCRA to obtain/share trial specific issues across all study sites with a focus on quality and metrics.
  • Communicate issues and escalate quality concerns according to Rho SOPs
  • Maintain TMF expectations outlined by TMF Business Process Owner
  • Set up Trial Master File in the eTMF at study, country and site level
  • Maintain the placeholders for the study by adding new placeholders, removing excused items, and adding events
  • Monitor and identify study TMF trends and completeness and escalate as needed
  • Assist the study teams in completing requirements for closing out the eTMF when the study is complete
  • Provide mentoring to RAs and In House CRAs

Qualifications

  • BA/BS required, advanced degree with scientific or health care training preferred
  • A minimum of 3 years’ experience working in a clinical research/clinical development industry
  • Relates well to all levels of staff, approachable and builds constructive and collaborative relationships
  • TMF experience required, including primary responsibility for TMF set-up, study start-up, maintenance and close-out
  • TMF Reference Model exposure preferred
  • Demonstrable knowledge of TMF business process and clinical trial activities
  • Ability to maintain high level of accuracy and attention to detail
  • Must exhibit professionalism, communicate effectively, and be a team player
  • Excellent organizational and analytical skills, sufficient to multi-task in an extremely fast-paced environment
  • Must have excellent computer skills, including experience in Word, Excel and PowerPoint, with ability to quickly and efficiently learn new eTMF and other computer systems
  • Ability to make decisions in a timely manner
  • Knowledgeable of FDA & ICH/GCP regulations and guidelines
  • Independently motivated with good problem solving ability

EOE. Veterans/Disabled