TMF Assistant – Clinical Trial Documentation Support
TRIO - Translational Research in Oncology · Edmonton
Description du poste
About the role
The TMF Assistant will support the Project Management team in maintaining the Trial Master File for oncology clinical studies. This position is primarily home‑based or hybrid, with occasional visits to the Edmonton office.
Key responsibilities
- Process study documentation according to SOPs, GCP, ICH guidelines and study‑specific TMF plans.
- Perform quality reviews of documents for the electronic TMF (eTMF) and resolve issues with the operational team.
- Upload documents to trial‑specific eTMFs, assign metadata, and ensure proper indexing.
- Maintain compliance with TRIO quality, performance and training requirements.
- Scan and index paper trial documents into the (e)TMF when required.
- Update eTMF oversight trackers and support the TMF Manager with reports, newsletters and meeting minutes.
Required profile
- High School Diploma.
- At least one year of relevant work experience.
- Proficiency with Microsoft Office and Adobe applications.
- Excellent organization, accuracy and attention to detail.
- Ability to work independently, self‑motivate and prioritize multiple tasks.
- Fluency in English (reading, writing, speaking).
Required skills
- Microsoft Office
- Adobe Acrobat
- eTMF (electronic Trial Master File) systems
- Data entry systems
What we offer
- Annual salary range $37,000–$41,000 CAD, with compensation reviews.
- 3 weeks vacation plus paid December holiday closure.
- 10 days paid personal/sick leave and 1 paid volunteer day per year.
- Comprehensive health, dental, vision and life insurance (premiums paid by TRIO).
- Up to 5% RRSP matching and voluntary TFSA program.
- Flexible working hours, monthly internet allowance, home‑office stipend and mobile phone stipend.
- Opportunities for short‑term international work, parental leave top‑up, employee assistance, recognition and referral bonuses.
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TRIO - Translational Research in Oncology
Edmonton
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