Clinical Safety Assistant

<span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">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.<br><br>TRIO is looking for a Clinical Safety Assistant (referred internally as a <b>Medical Affairs Assistant)</b><b> </b>to join our <b>Drug Safety Unit</b> team. Reporting to the <strong>Drug Safety Unit Manager</strong><b>, </b>this position will be <strong>remote</strong><b>-based </b>in<b> Canada. </b><br><br><b><u>Responsibilities:</u></b></span></span><ul><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Manage the distribution of safety reports to reviewing parties, including reception, tracking, distribution/submission, follow‑up on confirmation of receipt, and filing.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Manage the administrative aspects of Serious Adverse Event (SAE) reporting, including reception and tracking of SAE reports.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Perform data entry of designated SAE fields into the safety database.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Provide support to manage investigator site user access to the Safety Distribution System.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Provide support for Third Party Organization (TPO) oversight to ensure appropriate monitoring and follow‑up of safety reporting activities.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Set up trial-specific instructions for Medical Affairs documents applicable to Trial Master File (TMF) filing, including folder structure and file naming conventions.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Maintain timely TMF filing for Medical Affairs documents.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Maintain the TMF QC schedule, participate in QC activities, and support issue resolution.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Participate in the creation and revision of Trial Written Instructions (TWIs), as applicable.</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Provide administrative support to the Medical Affairs team in study-related activities (e.g., mailings, filing, team roster maintenance, document tracking, meeting minutes).</span></span></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"> <b><u>Qualifications:</u></b></span></span><ul><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Minimum diploma in a science-related field</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Minimum of two years’ experience as an administrative assistant or coordinator</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Fluent in written and spoken English</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Strong computer skills, including Outlook, Word, and Excel</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Strong attention to detail with excellent organizational skills</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Experience in a medical or clinical trials environment is considered an asset</span></span></li><li><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Medical knowledge is considered an asset</span></span></li></ul><div style="text-align:center;"><p style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><u><strong>What TRIO Can Offer You:</strong></u></span></span></p><ul><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Annual compensation review with opportunities for professional growth</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">3 weeks of vacation plus paid December Holiday Closure</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">10 days paid personal/sick time</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">1 paid volunteer day / year</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">A rich benefit plan with Health, Dental, Vision & Life Insurance premiums paid by TRIO</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Up to 5% RRSP Matching Program</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Flexible working hours to create work-life balance</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Monthly Internet Allowance to support working from home and a one-time Home Office Allowance</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Out-of-country Work: Employees can request to work internationally for a short period of time each year</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Maternity Leave Top-Up Program</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Employee Family Assistance Program to support you and your family during difficult times</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Employee Recognition Program to reward long-term employees</span></span></li><li style="text-align:left;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Employee Referral Bonus Program</span></span></li></ul><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">Pay Range: <b>$45,000.00 to $56,500.00</b> - Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.<br> </span></span><div style="text-align:center;"><img alt="" height="111" src="https://assets.jazz.co/customers/customer_20191115220729_58PHFUIXCSJP484O/layout/20260413164410-Canada's%20Top%20S&M%20Employers%20Logo.jpg" width="90"></div><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">  </span></span><div style="text-align:center;"><img alt="" height="111" src="https://assets.jazz.co/customers/customer_20191115220729_58PHFUIXCSJP484O/layout/20260325153358-Alberta's%20Top%20Employers%20Logo.jpg" width="81"></div><br><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">We thank all candidates for their interest; only those selected for an interview will be contacted.</span></span></div><p><span style="\"font-size:14px\""><span style="\"font-family:Arial,Helvetica,sans-serif\"">Prior to applying please review TRIO's <a href="\"https://drive.google.com/file/d/1OmkMw3kKL1z_Hic3hUqE_P34jSxWdEhT/view?usp=sharing\"">Applicant Information Notice</a></span></span></p> <p><span style="\"font-size:14px\""><span style="\"font-family:Arial,Helvetica,sans-serif\"">To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI.</span></span><br> <br> <span style="\"font-size:14px\""><span style="\"font-family:Arial,Helvetica,sans-serif\"">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.</span></span></p> <p style="\"text-align:center\""><strong><span style="\"font-size:20px\""><span style="\"font-family:Arial,Helvetica,sans-serif\"">Teamwork · Passion · Integrity · Innovation </span></span></strong></p>

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