Clinical Research Associate II 2 positions

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 groundbreaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.

AbbVies 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 peoples lives across several key therapeutic areas: immunology oncology neuroscience eye care virology womens 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 Clinical Operations R&D team. The Clinical Research Associate II 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 can be based in Quebec Ontario or Maritimes and reports to the Clinical Operations Manager.

Key responsibilities:

• For assigned sites/study(s) ensure successful protocol of SMM deliverables involving startup and closeout.
• Ensure siterelated study including but not limited to monitoring visits site evaluations site selection and activation are executed accordingly and monitoring closeout and visits are properly reported
• Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all sitespecific information are maintained and kept current.
• Provide local regulatory and legal requirements. Ensures timely payment for the assigned sites/study(s) are fulfilled according to the clinical study agreements and as per local requirements.
• Ensure adherence to best clinical practices ICH guidelines AbbVie standard operating procedures monitoring plans and 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 preaudit activities as per best clinical practice requirements.
• Prepare and followup site audits/inspections; provide input into the CAPA preparation.
• Responsible for coaching and mentoring clinical research associates and providing input into their development.
• May be asked to be the point of contact for an assigned study. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by the manager
• Provide consistent best practice approach to onboarding consolidating lessons learned across areas and monitoring and define training materials and curriculum to ensure effective training is delivered in a timely manner.

Qualifications :

Education / Experience required.

• Bachelors degree in Science related health field (e.g. Medical Scientific Nursing Pharmacy) preferred
• Solid knowledge of the biotech/pharmaceutical industry:
• Site Monitoring experience including (minimum of two years)
• All aspects of study monitoring; data drug accountability documentation experience.
• Ability to think and plan strategically (work plans activities timetables targeting) and operating with excellence.

Essential skills and abilities:

• Advanced English and 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 daytoday tasks).
• Travel required at least 5 of the time.
• Valid drivers license and passport.

Key leadership competencies:

• Demonstrate passion curiosity autonomy and flexibility.
• Operate and communicate effectively in a Matrix environment.
• Prepare and deliver effective storyline presentations.
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decisionmaking.
• Excellent interpersonal skills with the ability to communicate persuasively and with clarity flexibility and adaptability to changing requirements resourcefulness and creativity. Demonstrated proactive and positive team player.
• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
• Selfmotivated and autonomous.

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

Additional Information :

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 AbbVies 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Yes