Job Description

Job Title: Senior Clinical Research Associate
Location: Calgary, Alberta or Edmonton, Alberta
Type: SALARIED
Compensation: $130,000.00 - $150,000.00 CAD based years of experience and education
Hours: 40.0

Responsibilities

• Provide site management and support to external trial staff, including Principal Investigators and Study Coordinators, from trial initiation to closeout.
• Ensure the collection of high-quality data, timely adverse event reporting, participant protection, and adherence to the protocol.
• Maintain compliance with ICH-GCP, Canadian regulatory standards, local ethics requirements, Company SOPs, and Clinical Development Guidelines.
• Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual numbers to ensure targets are met.
• Collaborate regularly with the Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues impacting milestones.
• Train and support external trial staff on CRF and IVRS data entry, adverse event/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability, temperature monitoring, query resolution, essential document collection, and ITF filing.
• Identify objectives for scheduled monitoring visits and ensure they are achieved within SOP and protocol timelines.
• Prepare and complete monitoring visit reports and follow-up correspondence promptly.
• Complete system training (IMPACT, IV/WRS, EDC, CATS, CONCUR, etc.) to ensure compliance with protocols and SOPs.
• Use EDC and other data source systems proactively for site visit preparation, conduct, and source data verification in collaboration with data management and logistics teams.
• Identify potential risks early and implement proactive measures to prevent or mitigate issues.
• Participate in Sponsor and Regulatory audits in Canada, assisting in record preparation, addressing auditor questions, supporting external staff, and ensuring compliance with guidelines.
• Adhere to company policies, procedures, and standards, acting as a backup monitor as needed and performing other tasks as assigned.

Requirements

• Educational requirement: BA/BS or higher, required
• Minimum experience: 3 years of CRA monitoring experience from sponsor or CRO
• Ideally 4+ years of field CRA monitoring experience for drug trials
• Industry experience: 6+ years in clinical research
• Experience working with institution sites is a plus
• Ability to work independently with strong critical thinking skills
• Remote monitoring Experience
• Risk-Based Monitoring experience
• Complex trial experience is a plus
• Flexible, agile, excellent communication skills, and tech-savvy to learn new systems

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical

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