Contract Clinical Research Associate

PSI CRO

About The Position

PSI is a dynamic global company founded in 1995, with close to 3,000 staff, working on medical science and bringing new medicines to patients. As a Clinical Research Associate, you will perform a variety of monitoring tasks across clinical studies in different therapeutic indications while maintaining high quality standards. The role is based in Canada’s West Coast and requires travel of up to 75%.

Requirements

College or university degree in Life Sciences, or an equivalent combination of education, training, and experience.
Located in Canada (West Coast).
At least 5 years of independent on-site monitoring experience.
Experience with all types of monitoring visits in Phase I–III studies.
Experience independently monitoring Oncology clinical trials.
Experience independently monitoring Gastroenterology (IBD) clinical trials.
Proficiency in MS Office applications.
Ability to plan, multitask, and work in a dynamic team environment.
Communication, collaboration, and problem-solving skills.
Ability to travel up to 75%.
Valid driver’s license.

Responsibilities

Serve as the main line of communication between the project team, sponsor, and clinical site.
Build and maintain relationships with site staff involved in study conduct.
Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits.
Ensure subject recruitment targets are defined, communicated, recorded, and met in a timely manner, and that site-level project timelines are followed.
Maintain timely and accurate information flow with trial sites regarding adverse events and protocol or process deviations.
Perform source data verification, follow up on site-level data queries, and review and manage site-level study risks.
Ensure proper handling, use, accountability, reconciliation, and return of investigational products and clinical study supplies at sites.
Review essential study documents and reconcile the Investigator Site File and Trial Master File at site level.
Ensure site-level data integrity and compliance.
Conduct site audit preparation visits and resolve audit findings.
Participate in study site audits and client onsite visits as required.
Coordinate the flow of documents and study supplies between the project team, site, and central or regional laboratories, central reviewers, and warehouses.
Conduct project-specific training for site investigators.
Support preparation of investigator newsletters.
Support Site Management Associates in maintaining study-specific and corporate tracking systems at site level.
Support preparation of draft regulatory and ethics committee submission packages.
Support collection of IP-RED packages at site or country level.
Facilitate review and reconciliation of the study Trial Master File at country and site levels.