Clinical Research Associate II

AbbVie

. Proactively solve study-related clinical site issues and initiate, recommend, and communicate corrective action .

Posted 11/4/2026full-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 site monitoring, ensuring compliance with GCP, ICH Guidelines, and regulatory standards while effectively managing site personnel and study-related issues. Proficient in training site staff and maintaining regulatory inspection readiness.

Highest-signal resume keywords

Clinical Site MonitoringGCP ComplianceRegulatory KnowledgeInvestigational Trials ExperienceMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringStudy QualificationData ManagementDocumentation ExperienceSafety Event ReportingAction Plan ImplementationInvestigator Agreement NegotiationExpense ReportingTherapeutic Indications KnowledgeStudy Closeout

Soft Skills

Strong Planning SkillsOrganizational SkillsInterpersonal SkillsAnalytical CapabilitiesEffective Communication

Tools & Technologies

Microsoft Office SuiteClinical Trial Management SystemsMonitoring Tools

Industry Keywords

Clinical ResearchICH GuidelinesGCPFederal RegulationsStudy ProtocolsClinical TrialsHealth Related QualificationInvestigational Drug TrialsSite Personnel ManagementRegulatory Inspection Readiness

About the role

Key responsibilities & impact

Proactively solve study-related clinical site issues and initiate, recommend, and communicate corrective action
Monitor activities conducted by clinical investigative sites for AbbVie clinical studies
Ensure 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 motivate/influence them to meet study objectives
Proactively manage sites and implement action plans to ensure compliance
Ensure regulatory inspection readiness at assigned clinical sites
Ensure quality and timely submission of study-site data, including reporting and follow-up for safety events
Ensure safety and protection of study subjects through compliance with monitoring plans, SOPs, guidelines, and regulations
Train study site personnel on protocols and regulatory requirements
Manage investigator payments according to executed contract obligations
Negotiate investigator/hospital agreements with stakeholders
Maintain and complete expense reports according to applicable guidelines
Identify, evaluate, and recommend new or potential investigators and clinical sites

Requirements

What you’ll need

Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred
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 and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
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 and ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
Ability to work, understand and follow work processes within the assigned function
Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity
Ability to address study-related clinical site issues with appropriate guidance and initiate and communicate corrective action as indicated
Ability to use functional expertise and exercise good judgment
Demonstrated business ethics and integrity
A minimum of 50% travel is required
Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)
Must be at ease with technology and the use of various tools/systems to perform day-to-day tasks
Valid driver’s license and passport

Benefits

Comp & perks

Innovative work culture
Professional development
Paid time off: vacation, holidays, personal days, and volunteer days
Employee stock purchase
Wellness spending account
Flexible health insurance
Retirement savings programs
Bonus plan