Clinical Study Associate Jobs

The Clinical Study Associate (CSA) is an integral part of the study team, responsible for the creation, distribution and quality of clinical trial materials, tools and documents. The CSA ensures these activities are conducted in accordance with the client, study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and all applicable regulatory requirements. The position supports the Clinical Study Manager and Clinical Operations by tracking and reporting study metrics as well as by performing in-house office administrative activities to ensure efficient and effective study start-up and conduct, to drive projects forward in accordance with contract and client expectations.

• Are you a team player striving for continuous improvement?
• Do you want to make an impact and be recognized for your contributions?
• Do you want to work in a collaborative and supportive environment?
• Do you enjoy being faced with a challenge and troubleshooting innovative solutions?
• Do you provide excellent service to your customers?
• Are you driven by meeting or exceeding targets?

If you answered YES, we encourage you to apply!
Accountabilities

• Perform and track ethics and regulatory submissions
• Lead the set-up, maintenance and support of the technical systems such as CTMS and eTMF
• Identify and evaluate potential clinical study sites for study feasibility
• Assist with site contract preparation and distribution
• Assist the Clinical Study Manager in any functions as required
• Assist with timely distribution of Safety related notifications (e.g. SAEs)
• Prepare site payments and track payment activities
• Set-up, Maintain, File and Archive study files (electronic as well as physical Trial Master Files)
• Liaise with sites to update and correct information in a timely fashion
• Prepare, distribute, collect and review all essential study related documentation from sites for accuracy and completeness
• Timely submission of timesheets
• Prepare study binders and distribute study tools
• Prepare and send courier shipments
• Ensure client and investigator documentation obligations are being met and are in compliance with applicable regulatory requirements, client SOPs and ICH-GCP guidelines
• Quality Control of documents and medical supplies
• Attend study team meetings as required, write meeting minutes and prepare any study progress reports
• Work collaboratively with members of the study team to problem solve and promote progress

Qualifications

• Ability to organize, create and present study data in order to support metrics and business activities
• Strong interpersonal and customer service skills to promote effective working relationships with others
• Team player with initiative to learn and handle multiple assignments independently
• College or University degree in Sciences
• Excellent English communication skills (verbal and written) French is an asset
• Ability to prioritize and manage multiple projects concurrently
• Ability to maintain composure and function effectively under pressure
• Excellent organizational skills and attention to detail
• Ability to act as a liaison with vendors and other functional team members to meet project goals
• Above average problem-solving skills
• Minimum 2 years of experience in clinical research
• Self-motivated and proactive
• Excellent technical skills and experience with electronic systems such as CTMS, eTMF, and EDC
• Strives to streamline and improve processes supporting clinical operations and the business
• Proficiency using Microsoft Office Applications, and electronic spreadsheets is required
• Prior experience with eTMF, CTMS and other electronic systems is an asset