Clinical Research Associate II
3 weeks ago
Location: Canada, Montreal
Employment Type: Full-time
Job ID: JR119531
At 405 ICR Canada, our workforce is our greatest asset. Our diverse teams empower us to enhance our partnerships with clients and contribute to our mission of advancing patient care.
Our culture is founded on four core values that unite us as individuals and distinguish us as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aspire to be the Clinical Research Organization that consistently delivers excellence to our clients and patients at every interaction.
As a Clinical Research Associate, you will operate within a dynamic, large-scale environment alongside a dedicated team of skilled CRAs to identify, select, initiate, and close investigational sites for clinical trials in phases II – IV, ensuring compliance with relevant regulations and ICH-GCP principles.
Key Responsibilities:
- Conduct independent and proactive work to establish and oversee studies, complete reports, and maintain documentation.
- Prepare and submit protocol and consent documents for ethics/IRB approval, along with regulatory submissions.
- Manage sponsor-generated inquiries effectively.
- Ensure study cost efficiency and take responsibility for budget management.
- Prepare and review study documentation and feasibility assessments for new proposals.
- Potentially assist in the training and mentoring of junior CRAs.
Qualifications:
- Minimum of 18 months of monitoring experience in phase I-III trials as a CRA.
- Degree in medicine, science, or a related field.
- Prior monitoring experience in medium-sized studies, including start-up and close-out phases.
- Strong understanding of ICH-GCP guidelines and the ability to review and assess medical data.
- Exceptional written and verbal communication skills.
- Ability to meet tight deadlines.
- Willingness to travel at least 60% of the time (both international and domestic) and possess a valid driving license.
Benefits of Working at 405 ICR Canada:
Our success hinges on the caliber of our personnel. Therefore, we prioritize cultivating a culture that recognizes high performance and nurtures talent.
We offer competitive salary packages, regularly benchmarked against industry standards. Our annual bonuses reflect the achievement of performance goals – both organizational and individual. Additionally, we provide a comprehensive range of health-related benefits for employees and their families, along with competitive retirement plans.
405 ICR Canada is an equal opportunity employer committed to fostering a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If you require reasonable accommodation due to a medical condition or disability during the application process or to perform essential job functions, please inform us.
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