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 Clinical Safety Assistant (referred internally as a Medical Affairs Assistant) to join our Drug Safety Unit team. Reporting to the Drug Safety Unit Manager, this position will be remote-based in Canada.
Responsibilities:- Manage the distribution of safety reports to reviewing parties, including reception, tracking, distribution/submission, follow‑up on confirmation of receipt, and filing.
- Manage the administrative aspects of Serious Adverse Event (SAE) reporting, including reception and tracking of SAE reports.
- Perform data entry of designated SAE fields into the safety database.
- Provide support to manage investigator site user access to the Safety Distribution System.
- Provide support for Third Party Organization (TPO) oversight to ensure appropriate monitoring and follow‑up of safety reporting activities.
- Set up trial-specific instructions for Medical Affairs documents applicable to Trial Master File (TMF) filing, including folder structure and file naming conventions.
- Maintain timely TMF filing for Medical Affairs documents.
- Maintain the TMF QC schedule, participate in QC activities, and support issue resolution.
- Participate in the creation and revision of Trial Written Instructions (TWIs), as applicable.
- Provide administrative support to the Medical Affairs team in study-related activities (e.g., mailings, filing, team roster maintenance, document tracking, meeting minutes).
Qualifications:- Minimum diploma in a science-related field
- Minimum of two years’ experience as an administrative assistant or coordinator
- Fluent in written and spoken English
- Strong computer skills, including Outlook, Word, and Excel
- Strong attention to detail with excellent organizational skills
- Experience in a medical or clinical trials environment is considered an asset
- Medical knowledge is considered an asset
What TRIO Can Offer You:
- 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
- Flexible working hours to create work-life balance
- Monthly Internet Allowance to support working from home and a one-time Home Office Allowance
- Out-of-country Work: Employees can request to work internationally for a short period of time each year
- Maternity 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
Pay Range: $45,000.00 to $56,500.00 - Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.
We thank all candidates for their interest; only those selected for an interview will be contacted.Prior to applying please review TRIO's Applicant Information Notice
To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI.
To ensure fairness and an accurate understanding of your skills, we ask that candidates refrain from using AI tools or AI‑generated responses during interviews or assessments. We want the opportunity to get to know you and your experience.
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