Clinical Research Associate II

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

📋 Description

• Proactively identify and address clinical site issues related to studies, ensuring corrective measures are communicated effectively.

• Oversee activities at clinical investigative sites to facilitate successful execution of protocols.

• Ensure compliance with federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards.

• Conduct site qualification, initiation, interim monitoring, and closeout visits for studies in Phase I–III.

• Supervise site personnel activities and implement action plans to maintain compliance.

• Prepare assigned clinical sites for regulatory inspections.

• Guarantee the quality and timely submission of data from study sites, including reporting and follow-up on safety events.

• Safeguard the well-being of study participants by ensuring monitoring-plan and regulatory compliance.

• Provide training to study-site personnel on protocols and regulatory standards.

• Manage payments to investigators and negotiate agreements with investigators and hospitals.

• Complete expense reports in accordance with applicable guidelines.

• Identify, assess, and recommend potential investigators and clinical sites.

⛳️ Requirements

• A relevant tertiary health-related qualification (e.g., Medical, Scientific, Nursing) is preferred.

• A minimum of 2 years of experience in clinical monitoring is required.

• Experience in on-site monitoring of investigational drug or device trials is essential.

• Comprehensive knowledge of therapeutic indications pertinent to clinical trials.

• Strong understanding of clinical research regulations, ICH/GCP Guidelines, and relevant regulations.

• Familiarity with study monitoring, data management, drug accountability, and documentation procedures.

• Excellent planning and organizational skills.

• Ability to thrive in a dynamic environment with multiple projects and tight deadlines.

• Capability to comprehend and adhere to work processes.

• Strong analytical and conceptual skills.

• Effective interpersonal and communication abilities.

• Skillful in addressing clinical site issues and communicating necessary corrective actions.

• Good judgment, business ethics, and integrity are essential.

• Willingness to travel at least 50% of the time is required.

• Proficiency in Microsoft Office Suite, including Outlook, PowerPoint, Excel, and Word.

• Comfort with various technology tools and systems.

• A valid driver's license and passport are necessary.

🏝️ Benefits

• Innovative work culture.

• Opportunities for professional development.

• Paid time off including vacation, holidays, personal days, and volunteer days.

• Employee stock purchase program.

• Wellness spending account.

• Flexible health insurance options.

• Retirement savings programs.

• Bonus plan.