Contract Clinical Research Associate

This is a fully remote position, open to applicants in Canada.

📋 Description

• Serve as the primary communication link among the project team, sponsor, and site.

• Establish and nurture relationships with site personnel involved in the execution of the study.

• Prepare, execute, and report on site selection, initiation, routine monitoring, and close-out visits.

• Define, communicate, document, and achieve subject recruitment targets while adhering to project timelines at the site level.

• Ensure the accurate and timely exchange of information with trial sites regarding adverse events and deviations from protocols/processes.

• Conduct source data verification and follow up on data queries at the site level.

• Review and manage study-related risks at the site level.

• Manage the handling, usage, accounting, reconciliation, and return of investigational products and clinical study supplies.

• Review key study documents and reconcile the Investigator Site File/TMF at the site level.

• Ensure data integrity and compliance at the site level.

• Prepare for site audits and address findings from site audits.

• Participate in study site audits and client visits as necessary.

• Coordinate the flow of documents and study supplies among project teams, sites, laboratories, reviewers, and warehouses.

• Conduct project-specific training for site investigators.

• Assist in the preparation of the Investigator newsletter.

• Support Site Management Associates with study-specific and corporate tracking systems.

• Aid in the preparation of regulatory and ethics committee submission packages.

• Assist in the collection of IP-RED packages at the site/country level.

• Facilitate the review and reconciliation of the study TMF at both country and site levels.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a comparable combination of education, training, and experience.

• Residing in Canada (West Coast).

• Over 5 years of independent on-site monitoring experience.

• Familiarity with all types of monitoring visits during phases I-III.

• Required experience in independently monitoring Oncology clinical trials.

• Required experience in independently monitoring Gastroenterology (IBD) clinical trials.

• Proficient in MS Office applications.

• Ability to plan, multitask, and thrive in a dynamic team environment.

• Strong communication, collaboration, and problem-solving abilities.

• Willingness to travel up to 75% of the time.

• Possess a valid driver’s license.

🏝️ Benefits

• Employees have the option to work remotely.