Bilingual (Eng \& Fr) Clinical Research Associate II (2 positions)
Join AbbVie, a global leader in innovative medicines, dedicated to making a remarkable impact on patients' lives. We are hiring two Bilingual (English \& French) Clinical Research Associates (CRA II) to support our clinical trials across Canada, based in Quebec, Ontario, or the Maritimes.
Key Responsibilities:
- Monitor activities at clinical investigative sites to ensure successful protocol execution and compliance with regulations, GCPs, ICH Guidelines, SOPs, and quality standards.
- Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I-III trials.
- Oversee site personnel activities, motivate, influence, and ensure regulatory inspection readiness.
- Ensure data quality and timely submission, including safety reporting.
- Train site personnel on protocols and regulatory requirements.
- Manage investigator payments, negotiate agreements, and handle expense reports.
- Identify and evaluate potential investigators/sites for clinical studies.
Qualifications:
- Health-related tertiary qualification (e.g., Medical, Scientific, Nursing) preferred.
- At least 2 years of clinical monitoring experience, specifically in investigational drug or device trials.
- Deep knowledge of therapeutic areas, regulations, GCPs, and study monitoring processes.
- Strong organizational, analytical, communication skills, and ability to work effectively in a dynamic environment.
- Willingness to travel at least 50%, with a valid driver's license and passport.
Additional Skills:
- Proficiency with Microsoft Office Suite.
- Comfort with technology and various tools/systems.
- Fluency in English is essential, especially for employees outside Quebec, to communicate with clients, colleagues, and stakeholders effectively.
AbbVie is an equal opportunity employer committed to diversity and inclusion. We encourage women, Indigenous peoples, persons with disabilities, and visible minorities to apply.
