Contract Clinical Research Associate

PSI CRO; Calgary; On-site; CAD 90,000 - 130,000; Full time

Job summary

PSI CRO is seeking a Clinical Research Associate to perform on-site monitoring across multiple therapeutic indications, with a focus on Oncology and Gastroenterology (IBD) trials. The role requires building strong site relationships, overseeing monitoring visits, and ensuring data integrity and compliant TMF at country and site levels.

You will collaborate with project teams, sponsors, and sites, manage regulatory and ethical submissions, and support study audits and site training.

Qualifications

• Degree in Life Sciences or equivalent combination of education, training & experience.
• Based in Canada (West Coast).
• 5+ years of independent on-site monitoring experience.
• Experience in Oncology and Gastroenterology (IBD) trials.
• Proficiency in MS Office applications.
• Willingness to travel up to 75%.
• Valid driver’s license.

Responsibilities

• Act as the main line of communication between project team, sponsor and site.
• Build and maintain good relationship with site staff involved in study conduct.
• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits.
• Ensure recruitment targets are defined, communicated and met at site level.
• Manage adverse events and protocol deviations with trial sites.
• Perform source data verification and manage study risks at site level.
• Handle Investigational Product(s) and study supplies at sites.
• Review ISF/TMF at site level and ensure data integrity and compliance.
• Conduct site audits and support client onsite visits as required.
• Coordinate documents and study supplies between project team, site and labs.
• Provide site investigators with project-specific training.
• Assist in regulatory submissions and IP-RED packages as needed.

Skills

Independent monitoring

Oncology trials

IBD gastroenterology trials

Travel willingness

Team collaboration

MS Office proficiency

Education

Life Sciences degree or equivalent

Tools

MS Office

Job description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together close to 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

• Act as the main line of communication between the project team, sponsor, and the site
• Build and maintain a good relationship with the site staff involved in the study conduct
• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
• Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
• Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
• Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
• Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
• Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
• Ensures quality (data integrity and compliance) at site level
• Conduct site audit preparation visits and resolve site audit findings
• Participate in study site audits and client onsite visits, as required
• Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
• Conduct project-specific training of site investigators
• Support preparation of Investigator newsletters
• Assist 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/country level
• Facilitate review and reconciliation of the study TMF on country and site levels

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Located in Canada (West Coast)
• 5+ years of independent on-site monitoring experience
• Experience in all types of monitoring visits, in phases I-III
• Experience independently monitoringOncology clinical trialsrequired
• Experience independently monitoringGastroenterology (IBD) clinical trialsrequired
• 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