About AbbVie 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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 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 one of the Best Workplaces in Canada whereby 92% of our employees are proud to say they work for AbbVie. 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. When choosing your career path, choose to be remarkable. We have an opportunity for a Clinical Research Associate to join our Medical Operations team in the Canadian Affiliate . The Clinical Research Associate manages and monitors clinical studies and study sites in accordance with all relevant processes and procedures, as well as applicable regulations, ensuring delivery of data within the agreed parameters (quality/time). This position is based in Quebec and reports to the Senior Project Manager, Clinical Research. Key responsibilities: Manage sites for observational clinical studies. Manage and oversee the set-up and maintenance of regulatory documents/clinical trial master file. Identify critical issues and bring them to the attention of team members including local management, project managers, and members of the Global project team. Coordinate day-to-day project-related activities of contract monitors, clinical research organizations (CRO) central labs and other service providers as required. Plan and coordinate study supplies (study binders, laboratory, etc.). Acquire knowledge in and work according to standard operating procedures (SOPs), good clinical practices (GCP), relevant regulatory guidance and local law. Build relationships with current and potential investigators. Routine clinical monitoring of clinical sites for compliance with GCP, the study protocol, reporting of adverse events, accounting for study drugs, verification of study case reporting forms (CRF) data against source documents, and completion and filing of regulatory documents. Review trip reports (monitoring visit reports) completed by contract monitors or other team members. Assist in preparing study budgets and ensures payments. Ensure management is kept informed of study progress through trip reports, site, and enrollment updates. Assist with and track the resolution of queries generated by data management. Assist in drafting study protocols and designing CRFs, patient diaries, medication labels or other study materials when required. Assist in the selection and evaluation of sites when required. Initiate and train study sites. Assist in the organization and conduct of investigator meetings. Close-out of study sites. Qualifications Education / Experience required: Bachelor’s degree in Science. Experienced in all aspects of study monitoring: data monitoring, drug accountability, regulatory documents, etc. (minimum of one to three years). Solid knowledge of the biotech/pharmaceutical industry. Ability to think and plan strategically (work plans, activities, timetables, targeting) and operating with execution excellence. Proficiency in GCP and International Council for Harmonisation (ICH) guidelines. Essential skills and abilities: Advanced English language proficiency (oral and written). Intermediate level French language proficiency (oral and written). Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.). Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks): Proficient with eDC systems. Travel required at least 5% of the time. Valid driver’s license and passport Key leadership competencies: Strong communication skills. Ability to assimilate product and protocol knowledge quickly. Detail oriented and capable of meeting due dates. Good organization skills. Flexible and resilient. Good interpersonal skills. Comfortable working in a matrix environment. Self-motivated. AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply. Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.