Trial Master Files Record Specialist

7 days ago

Ridgefield, Connecticut, United States McInnis Inc. Full time
Job Description

Hybrid Position - Weekly Commute to Ridgefield, CT & Work from Home

Trial Master File Records Specialist (TRS) Responsibilities

The TRS will provide services onsite (hybrid position) at our Ridgefield, CT location supporting our Trial Master File (TMF) team. The TRS is responsible to provide operational expertise to trial teams and Trial Documentation Service (TDS), oversees the implementation of the TMF strategy for the trial and supports the core trial team in all aspects of TMF management, in inspections or audits and in continuous improvement projects.

Duties & Responsibilities:

As part of the TMF team, the TRS will:

  • Manage the workload for assigned trials (approx. 12-18)
  • Supports the CT Leader by providing and maintaining oversight and guidance related to TMF activities throughout the course of the trial
  • Collaborates with the core trial team and the LTRS to create, implement and maintain the list of trial-specific expected records throughout the course of the trial
  • Perform regular reviews for completeness, timeliness, and quality of the TMF during CT conduct and provide feedback to the responsible party.
  • Facilitate communication between the trial team and LTRS
  • Create the final list of trial, country & site-specific exceptions with input from LTRS' in all OPUs.
  • Inform the CT Leader about the list of exceptions
  • Confirm the archiving prerequisites have been met to support archiving.
  • Provide input into the TMF Operational Plan and TMF-related CRO processes for fully outsourcing trials
  • Support CAPA Leads in the development of actions and follow-up on assigned actions in the TMF area
  • Work on assigned projects in regard to continuous improvement

Experience and Skills Requirements:

  • 4 Year college degree with 2+ years of TMF experience and/or 5+ years of TMF experience
  • Strong communication skills
  • Proficiency in computer skills, with direct working experience in multiple electronic platforms such as but not limited to: Share Rooms, Clinical Trial portals, Central IRB portals, Time reporting portals, Learning portals, Access Databases, Microsoft Excel, Microsoft Skype, Adobe Acrobat Professional and scanning software etc.
  • Maintain expertise of currently assigned Sponsor SOPs, Working Instructions (WI) and where applicable, departmental practices.
  • Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor.
  • Expertise in TMF Reference Model and Document management system
  • Experience working in an international/intercultural/cross-functional environment
  • Excellent time management with the ability to prioritize
  • Be a highly motivated individual with the ability to think critically, that is detail oriented, can multi-task and understand the clinical trial process, meet deadlines, and keep a trial/site on track along with any other qualifications provided by Sponsor

Records Retention/Storage

All documents managed by TRS' will reside solely as electronic files in our systems and must remain within those systems with no local storage of documents outside of our firewall.

Additional Provisions:

  • Contractor will comply with the following Key Performance Indicators (KPIs). Both parties will mutually agree on metrics requirements and turnaround times.
  • LOS Compliance
  • TimeRecorder Compliance

Job Type: Full-time

Salary: $32.00 - $36.00 per hour

Benefits:

  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Day shift
  • Monday to Friday

Education:

  • High school or equivalent (Required)

Experience:

  • TMF: 2 years (Required)

Work Location: Hybrid remote in Ridgefield, CT 06877

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