Clinical Research Associate II

AbbVie

Clinical Research Associate II monitoring Phase I–III clinical trials for AbbVie, an innovative medicines company. Managing site compliance, data quality, safety reporting, and investigator relationships with at least 50% travel.

Posted 8/12/2026full-timeRemote • 🇨🇦 CanadaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH/GCP Guidelines and regulatory standards while effectively managing site personnel and investigator relationships. Proficient in training site staff and maintaining high-quality data submission and safety-event reporting.

Highest-signal resume keywords

Clinical Trial MonitoringICH/GCP GuidelinesRegulatory ComplianceSite Qualification and InitiationMicrosoft Office Suite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research RegulationsInvestigational Drug TrialsData ManagementDrug AccountabilityMonitoring Plans

Soft Skills

Strong Planning SkillsOrganizational SkillsInterpersonal SkillsAnalytical CapabilitiesClear Communication

Tools & Technologies

Microsoft Office SuiteOutlookPowerPointExcelWord

Industry Keywords

Clinical Investigative SitesProtocol ExecutionQuality StandardsSafety-Event ReportingTherapeutic Indications

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Monitor activities conducted by clinical investigative sites for AbbVie clinical studies
Ensure protocol execution and adherence to federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards
Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III studies
Oversee site personnel activities and implement action plans to ensure compliance
Ensure regulatory inspection readiness at assigned clinical sites
Ensure quality and timely submission of site data, including safety-event reporting and follow-up
Protect study subjects through compliance with monitoring plans, SOPs, ICH Guidelines, and applicable regulations
Train study site personnel on protocols and regulatory requirements
Manage investigator payments and negotiate investigator/hospital agreements
Complete expense reports
Identify, evaluate, and recommend new investigators and clinical sites

Requirements

What you’ll need

Appropriate tertiary qualification in a health-related field preferred, such as Medical, Scientific, or Nursing
Minimum 2 years of clinically related monitoring experience
Experience with on-site monitoring of investigational drug or device trials required
In-depth knowledge of therapeutic indications relevant to clinical trials
In-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations
Familiarity with study monitoring, data, drug accountability, and documentation
Strong planning and organizational skills
Ability to work effectively in a dynamic environment with competing projects and deadlines
Ability to understand and follow work processes
Strong analytical and conceptual capabilities
Interpersonal skills and clear communication ability
Ability to address clinical site issues and communicate corrective actions
Ability to exercise good judgment
Demonstrated business ethics and integrity
Minimum 50% travel required
Proficiency with Microsoft Office Suite, including Outlook, PowerPoint, Excel, and Word
Comfort using various technologies and systems for day-to-day tasks
Valid driver’s license and passport

Benefits

Comp & perks

Remote work option
Equal opportunity employment
Reasonable accommodation for applicants with disabilities