Clinical Research Associate I

at  AbbVie

Company Description
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.
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.
Job Description

REQUIREMENTS:

• Appropriate life-science or healthcare-related qualification or experience or equivalent work experience.
• One year of clinically-related experience in a medical profession, pharmaceutical, or diagnostic company is preferred. Current knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials is preferred.
• Knowledge of conducting industry-sponsored clinical research (e.g. Clinical study coordinator/ data manager, clinical trial assistant (or equivalent), regulatory document specialist) is preferred. Knowledge related to ICH/GCP Guidelines and applicable local regulations is preferred.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study-related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
• Demonstrated business ethics and integrity.
• You must be available to attend the head office, located in St-Laurent, QC, occasionally for training purposes.
• French and English language proficiency (oral and written).AbbVie strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the following requirement, advanced amount of knowledge of English / Fluency in English is an essential requirement for the position of Clinical Research Associate I including, but not limited to, for the following reasons:English speaking employees outside the province of Quebec.English speaking clients outside the province of Quebec.Anglophone region outside the province of Quebec.
  Additional Information
  AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.
  AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
  US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
  US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
  https://www.abbvie.com/join-us/reasonable-accommodations.htm

• 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.
  Qualifications