Clinical Research Associate I - Jobs in Montreal, Québec

Job Description

Job DescriptionJoining AbbVie means, you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients #39; lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is 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 strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. Key Responsibilities:

• Supports in the in-house organization, management and execution of projects to ensure the clinical trials are conducted, recorded, and reported in accordance with the protocol, federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
• Participates in the study startup activities and site opening activities as well as study conduct and site closure tasks.
• Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas, with appropriate supervision. Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures safety and protection of study subjects.
• Supports and/or conducts (accompanied) site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes, if applicable.
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. Appropriately escalates serious or outstanding issues.
• Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites. Reports monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, with appropriate supervision. Keep management informed of study progress through periodic updates.
• Supports with Clinical Trial Application submissions, including relevant informed consent local changes and translations into local language as required. Supports remote monitoring, if and as applicable.
• Assists in study budget preparation and clinical study agreement execution, including ensuring necessary payments are made according to executed agreements. Negotiates investigator/ hospital agreements with stakeholders. Maintains and completes own expense reports as per local and applicable guidelines. Supports new and innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations and conserve overall departmental operating costs.