Clinical Research Associate - QC
AbbVie
Saint-Laurent, QC
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 or the Project Manager.

Responsibilites:
  • Manage investigator sites: participating in Phase I to IV and PMOS clinical studies.
  • Organize and manage critical 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, CROs, central labs and other service providers as required.
  • Plan and coordinate study supplies (drug, laboratory, etc.).
  • Acquire knowledge in and work according to SOPs, GCP, relevant regulatory guidance and local law.
  • Routine clinical monitoring of clinical sites for compliance with GCP, the study protocol, reporting of adverse events, accounting for study drug, verification of study 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 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 Site Selection and Site Evaluation when required.
  • Initiate and train study sites.
  • Assist in the organization and conduct of investigator meetings.
  • Close-out of study sites.
  • Assist with audits and audit reports.
Requirements:
  • Bachelor degree related to Life Sciences.
  • 1 to 3 years of experience in a similar position.
  • Strong communication skills.
  • English, written and verbal must be at advanced level.
  • French, written and verbal, is expected to be at intermediate level.
  • Experiencedin all aspects of study monitoring (data monitoring, drugaccountability, 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 5 % 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.

Job Posting End Date: April 5, 2019