Clinical Research Associate I

AbbVie Inc; Montreal; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading company in the healthcare sector seeks a Clinical Research Associate I in Montreal. The role involves supporting clinical projects, managing investigative sites, and ensuring compliance with regulations. Ideal candidates will have a life sciences background and strong organizational skills. Proficiency in both French and English is essential due to client interactions. Join a team dedicated to making a significant impact on patients' lives.

Qualifications

• One year of clinical-related experience in medical, pharmaceutical, or diagnostic fields preferred.
• Knowledge of clinical research processes, GCP, ICH guidelines, and local regulations preferred.

Responsibilities

• Support the organization and execution of clinical projects ensuring compliance with protocols.
• Manage activities of clinical investigative sites across multiple protocols.
• Train site personnel on protocols and regulatory requirements.

Skills

Organizational skills

Analytical skills

Communication skills

Education

Relevant life sciences or healthcare qualification

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.

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We focus on several therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, along with products and services in our Allergan Aesthetics portfolio.

Key Responsibilities:

• Support the organization, management, and execution of clinical projects to ensure trials are conducted, recorded, and reported in compliance with protocols, regulations, GCPs, ICH Guidelines, SOPs, Monitoring Plans, and quality standards.
• Participate in study startup, site opening, conduct, and closure activities.
• Manage activities of clinical investigative sites across multiple protocols and therapeutic areas, ensuring data quality and timely submission, including safety reporting and subject protection.
• Support and conduct site qualification, initiation, monitoring, and closeout visits for Phase 1-4 studies following regulations and SOPs.
• Train site personnel on protocols and regulatory requirements, escalating issues as needed.
• Facilitate Quality Assurance audits, ensure inspection readiness, and report monitoring activities accurately. Keep management informed of study progress.
• Assist with Clinical Trial Application submissions and support remote monitoring activities.
• Help prepare study budgets, negotiate investigator/hospital agreements, and manage expenses. Support process improvements to enhance efficiency and reduce costs.

Qualifications:

• Relevant life sciences or healthcare qualification or equivalent experience.
• Preferred: One year of clinical-related experience in medical, pharmaceutical, or diagnostic fields.
• Knowledge of clinical research processes, GCP, ICH guidelines, and local regulations preferred.
• Strong organizational, analytical, and communication skills. Ability to manage multiple projects in a dynamic environment.
• Demonstrated business ethics and integrity.
• Availability to attend training at the St-Laurent, QC head office occasionally.
• Proficiency in French and English (oral and written).

AbbVie aims to provide a French working environment in Quebec. However, advanced knowledge of English is essential for this Clinical Research Associate I position, due to interactions with English-speaking clients and regions outside Quebec.

Additional Information:

AbbVie is an equal opportunity employer, encouraging applications from women, Indigenous peoples, persons with disabilities, and visible minorities.

For more information, visit this link. To request accommodations, see this page.