Job Description

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.

The CTA will be responsible for creating the TMF plan and maintaining the TMF. The successful candidate will also be responsible for assisting the Clinical Project Managers with ethics submissions, communications, meetings and study/site start up activities and documents.

The successful candidate will have the opportunity to work within a rapidly growing company based in scientific research and product development for the natural health/food/wellness sector.

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

We thank all candidates for their applications, however, only those candidates selected for an interview will be contacted.

Job Type: Full-time

Work Location: In person