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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Senior Clinical Research Associate, Quebec, 12 Month Contract

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Research & Development
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1907219 Requisition #
Join our Talent Community

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

 
This position reports to the Clinical Operations Manager.
 
Responsibilities:
  • For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
  • Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
  • Ensure adherence to 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. Stay abreast of new and/or evolving local regulations, guidelines and policies.
  • Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
  • Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
  • May be responsible for being the country point of contact for CROs for an assigned study. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
  • If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
  • If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
  • If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
  • If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site  

Requirements:


• Bachelor degree related to Life Sciences.
• Minimum 3 years of experience.
• Strong communication skills.
• English, written and verbal must be at advanced level.
• French, written and verbal, is expected to be at intermediate level.
• Experienced in all aspects of study monitoring (data monitoring, drug accountability, regulatory documents, etc.)
• Proficiency in GCP and ICH/HPB guidelines.
• 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.
• Self-motivated.
• Proficient with Word, PowerPoint, Outlook, Excel and of eDC systems.
• Comfortable working in a matrix environment.

Availability and willingness to travel 25 % of the time within Canada.

Valid passport is required.

AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.

Equal Employment Opportunity Employer

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.

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