Address
SalaryDate: November, 13, 2023
Location: Ottawa, ON, Montreal, QC, Toronto, ON
Remote: Yes
Business Unit: Health
Department: Pharma Clinical Research
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?
- Are you driven by meeting or exceeding targets?
- Do you provide excellent service to your customers?
- Do you enjoy being faced with a challenge and troubleshooting innovative solutions?
- Do you want to make an impact and be recognized for your contributions?
- Do you want to work in a collaborative and supportive environment?
Accountabilities
- Identify and evaluate potential Clinical Study sites for study feasibility
- Lead the set-up, maintenance and support of the technical systems such as CTMS and eTMF
- Set-up, Maintain, File and Archive study files (electronic as well as physical Trial Master Files)
- Assist with site contract preparation and distribution
- Prepare, distribute, collect and review all essential study related documentation from sites for accuracy and completeness
- Ensure client and investigator documentation obligations are being met and are in compliance with applicable regulatory requirements, client SOPs and ICH-GCP guidelines
- Liaise with sites to update and correct information in a timely fashion
- Perform and track ethics and regulatory submissions
- Prepare study binders and distribute study tools
- 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
- Prepare site payments and track payment activities
- Quality Control of documents and medical supplies
- Prepare and send courier shipments
- Assist with timely distribution of Safety related notifications (e.g. SAEs)
- Assist the Clinical Study Manager in any functions as required
- Timely submission of timesheets
- Minimum 2 years of experience in clinical research
- College or University degree in Sciences
- Ability to prioritize and manage multiple projects concurrently
- Excellent organizational skills and attention to detail
- Excellent technical skills and experience with electronic systems such as CTMS, eTMF, and EDC
- Team player with initiative to learn and handle multiple assignments independently
- Self-motivated and proactive
- Ability to act as a liaison with vendors and other functional team members to meet project goals
- Above average problem-solving skills
- Strong interpersonal and customer service skills to promote effective working relationships with others
- Ability to maintain composure and function effectively under pressure
- Strives to streamline and improve processes supporting clinical operations and the business
- Ability to organize, create and present study data in order to support metrics and business activities
- Proficiency using Microsoft Office Applications, and electronic spreadsheets is required
- Prior experience with eTMF, CTMS and other electronic systems is an asset
- Excellent English communication skills (verbal and written) French is an asset
Calian employs over 4,400 people in its delivery of diverse products and solutions for private sector, government and defence customers in North American and global markets. The Company’s diverse capabilities are delivered through 4 services lines: Advance Technologies, Health, Learning and IT & Cyber Solutions.
Headquartered in Ottawa (Canada) the Company’s offices and projects span Canada and international markets. For further information, please visit the website at www.calian.com (https://www.calian.com/).
