Job Title

Chloe O'Shea has partnered with a mid-sized, global clinical research organization (CRO) known for its tailored and innovative clinical trial solutions. We are seeking an experienced Clinical Research Associate (CRA) to be the first CRA based in Canada for a single-sponsor opportunity. This is a unique chance to establish and grow clinical operations in Italy, with full backing and support from a highly engaged leadership team.This role offers a manageable workload of 58 site visits per month, enabling you to focus on high-quality monitoring, relationship building, and strategic site management.The RoleAs a Clinical Research Associate (CRA), you will be a pivotal contributor to the expansion and execution of clinical trials within Canada. Collaborating closely with a supportive international management team and dedicated sponsor, you will ensure protocol adherence, regulatory compliance, and quality-driven site monitoring. This opportunity is ideal for a seasoned CRA ready to take the next step by spearheading country-level clinical operations in a dynamic and empowering environment.Key ResponsibilitiesConduct pre-site, site initiation, monitoring, and close-out visits; prepare reports and ensure adherence to SOPs, SMMP, and protocol requirements.Train site staff during start-up, oversee collection of essential documents, and ensure accuracy of the Site Master File and Delegation of Duties log.Perform Source Document Verification (SDV), ensure compliance with inclusion/exclusion criteria, SAE reporting, informed consent accuracy, and investigational product handling.Monitor eCRF data entry, facilitate timely query resolution, and ensure investigator compliance with approved protocols and amendments.Verify proper storage of drug supplies, ensure filing of sponsor status reports, and resolve QA findings at assigned sites within required timelines..RequirementsA Bachelors degree in life sciences, nursing, pharmacy, or a related discipline.A minimum of 5 years of independent CRA experience, including lead or regional responsibilities.Solid understanding of Canadian regulatory frameworks and international ICH-GCP standards.Demonstrated ability to conduct monitoring activities across various therapeutic areas.Fluent in English, both spoken and written.Self-driven, with excellent communication, planning, and time management skills.Whats in It for You?Competitive salary.Opportunity to build and shape clinical operations in Italy with strong international support.Clear path for career advancement within a growing global CRO.Flexible work model with manageable travel expectations.Access to advanced tools, technologies, and methodologies in clinical research.Comprehensive health coverage and employee wellness initiatives.If youre a motivated, experienced CRA ready to make a lasting impact as the first in-country CRA for an expanding organization, wed love to hear from you. Apply now to be part of a team committed to excellence and innovation in clinical trials!