Clinical Research Associate II

AbbVie Inc; Mississauga; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical company is seeking a Clinical Site Manager in Mississauga to oversee clinical trial activities at investigative sites. The ideal candidate will have a tertiary qualification in a health-related field and at least 2 years of monitoring experience. Responsibilities include ensuring protocol adherence, managing investigator relations, and maintaining compliance with regulations. This role offers a competitive salary and requires travel approximately 50% of the time.

Qualifications

• Minimum of 2 years of clinically-related monitoring experience.
• Deep knowledge of therapeutic indications related to clinical trials.
• Understanding of regulations governing clinical research.

Responsibilities

• Monitor activities at clinical investigative sites for protocol execution.
• Conduct site qualification and monitoring visits for Phase I to III studies.
• Manage investigator payments and negotiate agreements.

Skills

Planning

Communication

Analytical skills

Education

Tertiary qualification in health-related field

Tools

Microsoft Office Suite

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is recognized as one of the Best Workplaces in Canada.

When choosing your career path, choose to be remarkable.

Job Description

To enable AbbVie's emergence as a world-class R&D organization, this position anticipates and proactively resolves study-related clinical site issues as they occur. It initiates, recommends, and communicates corrective actions to ensure successful protocol-level execution of Clinical Site Management deliverables, including start-up, execution, and close-out of studies.

Key Responsibilities:

• Monitor activities conducted by clinical investigative sites to ensure successful protocol execution, adherence to regulations, GCPs, ICH Guidelines, SOPs, Monitoring Plans, and quality standards.
• Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III studies, complying with applicable regulations and standards.
• Oversee activities of site personnel, motivate and influence them to meet study objectives, and ensure regulatory inspection readiness.
• Ensure the quality and timely submission of data from study sites, including safety reporting and follow-up.
• Protect study subjects' safety through compliance with monitoring plans, SOPs, GCPs, and regulations.
• Train study site personnel on protocols and regulatory requirements collaboratively with project team members.
• Manage investigator payments, negotiate agreements, and handle expense reports.
• Identify and evaluate potential investigators/sites, supporting the placement of clinical studies with qualified investigators.

Qualifications:

• Appropriate tertiary qualification, preferably in a health-related field (e.g., Medical, Scientific, Nursing).
• Minimum of 2 years of clinically-related monitoring experience, including on-site monitoring of investigational trials.
• Deep knowledge of therapeutic indications related to clinical trials.
• Understanding of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.
• Experience with study monitoring, data and drug accountability, and documentation.
• Strong planning, organizational, analytical, and communication skills.
• Ability to address site issues proactively and exercise good judgment.
• Demonstrated business ethics and integrity.
• Willingness to travel at least 50% of the time.

Additional Information:

• Proficiency with Microsoft Office Suite and comfort with technology.
• Valid driver’s license and passport required.

AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, and serving our community. We welcome applicants from all backgrounds.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

Applicants seeking reasonable accommodations can find more information at https://www.abbvie.com/join-us/reasonable-accommodations.html.