Clinical Trial Assistant

6 months ago

Guelph, Canada Nutrasource Full time

**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 clinic located in Guelph. The role is on site in Guelph ON.

The Clinical Trial Associate provides support to one or more cross functional project teams to ensure that high quality deliverables are met within budget and timelines. They will assist in the coordination and execution of activities for the implementation and management of all components of any active clinical study. They will additionally ensure the creation, maintenance and delivery of the Trial Master File (TMF), ethics submissions and communications along with study/site start up activities.

**Primary Responsibilities**:

- Supports the clinical study team in the overall management of studies, including planning, execution and closeout of both on-site and off-site clinical trials
- Assists the Project Managers in investigator site management activities, including review of site communication, tracking of site visits and expenses, and collection of site documents for TMF from sites
- Works closely with Project Managers to assist with preparation of external and internal documentation for assigned projects to ensure completion in accordance with GCP regulatory requirements and the study protocol
- Assists in the creation of and distribution of study materials, site binders and communications to sites, monitors and other external vendors
- Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established timelines; maintains up-to-date documentation for assigned study sites globally
- Assists the clinical study team with planning, preparation and where required, on-site support of SIV’s, Investigator meetings or monitoring visits
- Supports invoice and budget activities
- Develops, maintains and manages appropriate study documentation including TMF filing
- Collects, reviews and approves site regulatory documents; works with clinical study team and Clinical Regulatory Affairs Specialist to compile required documents for submission to ethics committees and regulatory agencies
- Coordinates communication of tracking information within clinical study team and to investigator sites
- Ensures TMFs are archived in accordance with regulations and contractual obligations
- Works with clinical and other internal departments to identify and resolve challenges

**Core Competencies**:

- Experience in the creation and maintenance of TMF
- Experience in supporting early development clinical trials
- Capability to manage multiple assignments and shifting priorities
- Prior exposure to nutraceutical/pharmaceutical/biotech research
- Experience with working with CROs, vendors, or consultants preferred
- Excellent organizational and time management skills; can work well under pressure and can prioritize multiple concurrent projects/assignments and meet established timelines
- Excellent communication and interpersonal skills to effectively interface with others
- Proficient in the use of MS Word, Excel, PowerPoint and Project

**Qualifications**:

- Bachelor’s Degree or equivalent in health sciences
- A minimum of 3 years of supporting clinical studies and document management at a CRO or biotech/pharmaceutical/ nutraceutical company
- Working knowledge of ICH-GCP, Health Canada and FDA regulations
- Must have 1 year TMF experience

**Job Types**: Full-time, Permanent

Schedule:

- 8 hour shift

Work Location: In person

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