Clinical Research Associate II

AbbVie

Clinical Research Associate II overseeing clinical site activities for AbbVie. Responsible for monitoring studies, ensuring compliance, and training site personnel.

Posted 6/30/2026full-timeRemote • 🇨🇦 CanadaJuniorMid-Level💰 CA$81,000 - CA$131,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH/GCP Guidelines and federal regulations while maintaining data quality and regulatory inspection readiness. Proficient in training site personnel and managing multiple projects in a dynamic environment.

Highest-signal resume keywords

Clinical Trial MonitoringICH/GCP GuidelinesRegulatory ComplianceData Quality AssuranceSite Training

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Monitoring ExperienceInvestigational Drug TrialsStudy MonitoringData DocumentationDrug Accountability

Soft Skills

Planning SkillsOrganizational SkillsEffective Communication

Tools & Technologies

Microsoft Office Suite

Industry Keywords

Good Clinical PracticesFederal RegulationsClinical ResearchSite QualificationStudy Closeout

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol.
Ensures 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.
Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase I to III studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
Ensures regulatory inspection readiness at assigned clinical sites.
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.
Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis.

Requirements

What you’ll need

Minimum of 2 years of clinically-related monitoring experience.
Experience in on-site monitoring of investigational drug or device trials is required.
Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
Familiarity with all aspects of study monitoring; data, drug accountability, documentation experience.
Strong planning and organizational skills.
Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.
A minimum of 50% travel is required.
Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible working hours
Paid time off