TRIO is a unique, full-service clinical research organization (CRO) that leverages the strengths of our worldwide network of Investigators, academic leaders, patient advocates and our clinical research team to accelerate drug development.
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.
Responsibilities:
This position is responsible for performing any/all of the following tasks and responsibilities, as
well as any other tasks deemed appropriate by the Supervisor:
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)
Qualifications:
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
Previous experience in data entry system preferred
English fluency (ability to read, write, speak)
What TRIO Can Offer You:
Competitive salary
3 weeks of vacation plus paid Christmas Closure
2 weeks paid personal/sick time
Health, Dental, Vision & Life Insurance premiums paid by TRIO
Flexible working hours
Monthly internet allowance
Up to 5% RRSP Matching Program
Pay Range: $35,000.00 to $45,000.00 - Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.
All interviews are currently being conducted virtually - via phone or video. We thank all candidates for their interest; only those selected for an interview will be contacted.
Innovation • Teamwork • Passion • Integrity
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