Clinical Research Assistant- Full time- Clinical Trials
3 weeks ago
We are looking for a Clinical Trial Assistant to support our Clinical Operations team in the management and execution of multiple projects at the company. various aspects of research studies administration. valuable insight into the Clinical Research field and the clinical trial
Clinical Trial Assistant (CTA)
ViTAA Medical Solutions Inc. is a new Canadian medical device company that is developing image analysis software to guide treatment of aortic aneurysms. ViTAA is a medical device company with offices in Montreal, and key personnel in Calgary and Toronto. The successful candidate must be a resident of Canada and would be expected to work remotely and have significant interaction with different teams at the company, with a particular focus on supporting the Clinical Operations division.
As Clinical Trial Assistant, your primary responsibility will be to ensure that the Company’s pre-clinical and clinical research studies are documented under Quality Standards. Ensure proper clinical trial documentation and record keeping:
Overseeing the Trial Master File for each of the clinical investigative sites
Working with VP of Clinical Operations to ensure Site Master Files are ready for audits and inspections by the Regulatory Bodies.
Working with the Clinical and regulatory Departments to revise the Clinical SOPs supporting clinical processes
· Ensure proper logistics during clinical trials
Overseeing study supplies such as binders, are delivered and received by the sites, initially and throughout the study.
Organizing and preparing for investigator meetings, site initiation, and monitoring visits.
· Supporting the development and maintenance of all the Company’s key clinical research documents (protocols, investigator brochures, case report forms, etc.)
· Supporting the preparation and completion of the proper documentation for pre-clinical and clinical studies, including final study reports.
· Supporting the implementation of EDC system, including coding of CRF, data collection, data entry, and quality control activities as needed.
· Bachelor's or master's degree program in a relevant field (e.g., life sciences, clinical research, pharmacy, etc.).
· Good Clinical Practice (GCP) certification including Data Management practices governed by ISO 14155 2020 and FDA: Guidance for Industry: Computerized Systems Used in Clinical Trials and 21 CFR Part 11 (asset)
· Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with electronic document management systems. (Office suite, cloud-based applications)
· Prior experience in clinical research, scientific research projects or regulatory affairs is an asset .
· Strong interest in Clinical Research and Medical Devices development ( asset )
Excellent written and verbal communication skills in English and French and strong interpersonal skills
· Experience in project management
· com ) Please include "Remote Clinical Trial Assistant in the subject line of your email.
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