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Clinical Research Associate
AbbVieClinical Research Associate managing investigative sites for AbbVie, a pharmaceutical company developing innovative medicines. Ensuring compliant trial execution, data integrity, patient safety, and site performance in Seoul.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research monitoring, including risk-based monitoring and compliance with ICH/GCP Guidelines. Capable of fostering strong relationships with investigative sites and stakeholders while ensuring high-quality outcomes in clinical trials.
Highest-signal resume keywords
Clinical Research MonitoringICH/GCP GuidelinesRisk-Based MonitoringStakeholder EngagementSite Training and Evaluation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial ConductRegulatory ComplianceData SubmissionPatient Recruitment TechniquesScientific Concept Application
Soft Skills
Cross-Functional CollaborationPlanning and Organizational SkillsInterpersonal SkillsActive ListeningPresentation Skills
Tools & Technologies
CRM ToolsMonitoring Tools
Industry Keywords
Clinical Development PipelineInvestigational Drug TrialsSite ManagementAudit ReadinessPatient Safety
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Advance AbbVie’s clinical development pipeline by delivering high-quality clinical research.
- Serve as the primary point of contact for investigative sites.
- Provide clinical-trial context and connect stakeholders with investigative sites.
- Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles.
- Conduct site evaluation, training, routine monitoring, and site-closure activities in compliance with protocols, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.
- Customize site-engagement strategies and track progress using CRM tools.
- Connect study protocols and scientific principles to day-to-day trial execution.
- Evaluate recruitment and retention techniques based on the patient disease journey.
- Mentor and train less experienced CRAs and contribute to their development.
- Participate in global or local task forces and initiatives.
- Conduct continuous risk assessment and collaborate with Central Monitoring to identify study-performance or patient-safety issues.
- Implement preventative and corrective action plans to mitigate risk and promote compliance.
- Identify, evaluate, and recommend investigators and clinical sites.
- Ensure timely, accurate site data submission and appropriate safety-event reporting and follow-up.
- Maintain audit and regulatory-inspection readiness at assigned sites.
- Manage investigator payments according to executed contracts, as applicable.
Requirements
What you’ll need- Appropriate tertiary qualification in a health-related discipline such as Medical, Scientific, or Nursing is preferred, not required.
- Minimum 1 year of clinically related experience.
- At least 6 months of clinical research monitoring experience involving investigational drug or device trials.
- Familiarity with risk-based monitoring and onsite/offsite monitoring.
- Knowledge of relevant therapeutic-area indications is preferred.
- Ability to understand and apply scientific concepts to clinical-trial conduct.
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
- Strong cross-functional collaboration skills with internal and external stakeholders.
- Strong planning and organizational skills; ability to manage competing projects and deadlines.
- Advanced ability to leverage technology, tools, and resources for site support.
- Strong interpersonal, written, verbal, active-listening, and presentation skills.
- Ability to establish site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to apply functional expertise, critical thinking, and sound judgment to clinical-site issues.
- Ability to act with integrity according to AbbVie’s code of business conduct and leadership values.
- Self-motivated and focused on timely, high-quality outcomes in a fast-paced environment.
Benefits
Comp & perks- Remote work option
- Equal opportunity employment
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community