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Senior Clinical Research Associate
AbbVieSenior Clinical Research Associate monitoring AbbVie clinical trials in Toronto. Ensuring site compliance, data integrity, patient safety, recruitment, and investigator partnerships.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including site evaluation, monitoring, and compliance with ICH/GCP Guidelines. Proven ability to develop site engagement strategies and mentor junior staff while ensuring quality outcomes in a fast-paced environment.
Highest-signal resume keywords
Clinical Research MonitoringICH/GCP GuidelinesSite Evaluation and TrainingRisk-Based MonitoringCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial ManagementSite MonitoringRegulatory ComplianceData SubmissionPatient Recruitment TechniquesSafety-Event ReportingSite Closure MonitoringInvestigational Drug TrialsTherapeutic-Area KnowledgeContinuous Risk Assessment
Soft Skills
Advanced Communication SkillsOrganizational SkillsInterpersonal SkillsCritical ThinkingMotivational Skills
Tools & Technologies
Clinical Trial Management SystemsMonitoring ToolsData Tracking ToolsPatient Engagement Platforms
Industry Keywords
Clinical TrialsGCP ComplianceICH GuidelinesHealth-Related DisciplineInvestigative Sites
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Advance AbbVie's clinical research pipeline by supporting clinical trials and translating science into medicine.
- Partner with study teams, internal R&D stakeholders, investigators, and site staff.
- Serve as the primary sponsor point of contact for the investigative site.
- Provide trial context, connect stakeholders to investigative sites, and strengthen AbbVie’s clinical-trial partnerships.
- Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles.
- Mentor and train junior CRAs and support local onboarding.
- Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring.
- Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards.
- Develop and apply site-engagement strategies; gather local/site insights and track strategy impact.
- Develop recruitment and retention techniques based on the patient disease journey.
- Conduct continuous risk assessment with the Central Monitoring team to identify study-performance and patient-safety issues.
- Identify, evaluate, and recommend investigators and sites for clinical studies.
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up.
- Maintain audit and regulatory inspection readiness at assigned sites.
- Manage investigator payments according to executed contract obligations, as applicable.
- Participate in or lead global/local task forces and initiatives.
- Perform additional activities assigned by the manager.
Requirements
What you’ll need- Appropriate tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
- Minimum of 3 years of clinically related experience
- Preferably 2 years of independent clinical research monitoring experience for investigational drug or device trials
- Familiarity with risk-based monitoring, including onsite and offsite monitoring
- Knowledge of therapeutic-area indications and ability to apply scientific concepts to clinical-trial conduct
- Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Advanced communication and cross-functional collaboration skills
- Superior planning and organizational skills; ability to manage competing projects and deadlines
- Ability to leverage technology, tools, and resources for customer-centric site support
- Superior interpersonal, written, verbal, active-listening, and presentation skills
- Ability to establish site relationships and trusted partnerships through engagement, motivation, and training
- Ability to independently apply functional expertise, critical thinking, and sound judgment to clinical-site issues
- Integrity in accordance with AbbVie’s code of business conduct and leadership values
- Self-motivated focus on timely, quality outcomes in a fast-paced environment
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