Clinical Trial Assistant
2 days ago
**Job description**
**Position Overview**
Our rapidly expanding team is looking for a **Clinical Trial Assistant (CTA)**/ **Trial Master File Administrator** who can work for us on a full time basis, supporting our Project Management Team located in Guelph.
**Primary Responsibilities**:
Oversight and management of the TMF including, but not limited to:
- Manage both electronic and paper filing system for trial documentation
- Track, maintain, and perform quality check of received documents
- Ensure TMF completeness
Oversight and management of clinical site documents including but not limited to:
- Identify, track, and review site content across multiple sites and studies
- Prepare ISFs and supplies for site start ups
- Ensure all documents are collected from site for site activation
Oversight and management of Ethics submissions for multiple studies including, but not limited to:
- Completing/assisting with ethics submissions and/or communication with ethics committees for each project to ensure timely approvals (central and local submissions)
- Completing/assisting sites with their ethics submissions and communications with the ethics committees.
Working with assigned Project Managers for study oversight including, but not limited to:
- Attending internal/external study meetings and completion of meeting minutes
- Creating standard documents for execution such as Project Management Plans, Trial Master File Plans, Participant Diaries, and other documents dependent on the study
- Assisting in the start up, oversight and close out of clinical trials
**Core Competencies**:
High attention to detail Excellent organizational skills
Strong written and verbal communication skills
Proficient in the use of MS Word, Excel, PowerPoint and Project
Excellent organizational and time management skills; can work well under pressure, prioritize multiple concurrent projects/assignments and meet established timelines
Excellent computer skills
**Qualifications**:
Bachelor’s Degree or equivalent in health sciences
Clinical research experience or training is an asset
Some experience in document administration
Experience with document management activities is an asset
Work Location: In person
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