TMF (Trial Master File) Assistant

Translational Research in OncologyEdmonton, AB
CA$37,000 - CA$41,000Hybrid

About The Position

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a TMF Assistant to join our Project Management team. Reporting to the TMF Manager. While this position will be primarily home-based or hybrid, depending on the candidate's preference, going into the Edmonton, Alberta Office to complete certain tasks may be required.

Requirements

  • High School Diploma
  • One year of work experience
  • Proficiency in MS Office and Adobe
  • Excellent organization skills, accuracy and detail oriented
  • Ability to work independently, be self-motivated and prioritize work effectively, ability to work on multiple tasks
  • English fluency (ability to read, write, speak)

Nice To Haves

  • Previous experience in data entry system preferred

Responsibilities

  • Processing study documentation per Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study-specific TMF Plans
  • Performing quality review of documents submitted for filing into the electronic Trial Master File (eTMF) and liaising with the operational team to resolve any issue identified
  • Uploading documents into the respective trial-specific eTMFs and assigning document metadata
  • Maintaining compliance with TRIO requirements (quality, performance and training)
  • If applicable, ensure paper trial documents are scanned and indexed into the (e)TMF
  • Maintaining any eTMF oversight trackers if applicable
  • Providing support to the TMF Manager as needed (e.g., running reports and metrics, preparing newsletters and meeting minutes)

Benefits

  • Annual compensation review with opportunities for professional growth
  • 3 weeks of vacation plus paid December Holiday Closure
  • 10 days paid personal/sick time
  • 1 paid volunteer day / year
  • A rich benefit plan with Health, Dental, Vision & Life Insurance premiums paid by TRIO
  • Up to 5% RRSP Matching Program
  • Voluntary TFSA Program Available
  • Flexible working hours to promote work-life balance
  • Monthly Internet Allowance to support working from home
  • Work arrangement options (Office-Based/Hybrid/Home Based) with a one-time Home Office Allowance
  • Mobile Phone Stipend available for qualifying positions
  • Out-of-country Work: Employees can request to work internationally for a short period of time each year
  • Maternity / Parental Leave Top-Up Program
  • Employee Family Assistance Program to support you and your family during difficult times
  • Employee Recognition Program to reward long-term employees
  • Employee Referral Bonus Program
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