CRA II

Job summary

Conduct assigned site qualification, initiation, monitoring, and closeout activities while verifying protocol, GCP, and regulatory compliance and protecting trial participants. Review source data, essential documents, and site processes; follow up on findings and risks; and communicate with investigators, site staff, and study teams.

Job details

Clinical Research Associate- Canada- Toronto At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. As a CRA II at ICON, you will perform site qualification, initiation, monitoring and closeout activities as assigned. What You Will Do You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key Responsibilities Include Perform site qualification, initiation, monitoring and closeout activities as assigned. Verify protocol, GCP and regulatory compliance and participant protection. Review source data, essential documents and site processes for accuracy and completeness. Identify and follow up findings, risks and corrective actions. Maintain clear communication with investigators, site staff and study teams. Required Qualifications And Experience Relevant life sciences, healthcare or clinical research qualification, or equivalent relevant clinical research experience. Minimum of 2 years of experience as a Clinical Research Associate. In-depth knowledge of clinical trial processes, regulations, and ICH Good Clinical Practice (GCP) guidelines. Knowledge of ICH Good Clinical Practice (GCP), clinical trial conduct and site monitoring requirements. Practical experience with site monitoring or site management appropriate to the level of role. Experience performing site qualification, initiation, monitoring and closeout activities as assigned. Experience verifying protocol, GCP and regulatory compliance and participant protection. Preferred Qualifications And Experience Therapeutic area expertise relevant to assigned studies. Experience with risk based monitoring or centralised monitoring approaches. Experience with clinical trial management systems (CTMS), electronic data capture (EDC) and electronic trial master file systems. Working conditions Willingness to travel as required (approximately 60%). What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

What you’ll do

Conduct assigned site qualification, initiation, monitoring, and closeout activities while verifying protocol, GCP, and regulatory compliance and protecting trial participants. Review source data, essential documents, and site processes; follow up on findings and risks; and communicate with investigators, site staff, and study teams.

Requirements

Requires a relevant life sciences, healthcare, or clinical research qualification, or equivalent relevant experience, and at least two years of experience as a Clinical Research Associate. Candidates should have in-depth knowledge of clinical trial processes, regulations, and ICH GCP, along with practical site monitoring or site management experience; therapeutic-area expertise and experience with risk-based monitoring and clinical trial systems are preferred.

Benefits

• Annual Leave
• Health Insurance
• Retirement Planning
• Employee Assistance Programme
• Life Assurance
• Childcare Vouchers
• Bike Purchase Schemes
• Discounted Gym Memberships
• Subsidized Travel Passes
• Health Assessments

Listed skills

• Regulatory Compliance · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Trial Monitoring
• Site Qualification
• Site Initiation
• Site Monitoring
• Site Closeout
• ICH Good Clinical Practice
• Regulatory Compliance
• Participant Protection
• Source Data Review
• Essential Document Review
• Risk Identification
• Corrective Action Follow-Up
• Investigator Communication
• Risk-Based Monitoring
• Clinical Trial Management Systems
• Electronic Data Capture

Job areas

• Healthcare
• Science & Research

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