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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research management, ensuring compliance with ICH/GCP Guidelines and local regulatory requirements while effectively engaging and training site staff. Leverages strong planning, organizational, and interpersonal skills to drive successful clinical trial execution and maintain data quality.
Highest-signal resume keywords
Clinical Research MonitoringICH/GCP Guidelines KnowledgeSite Engagement StrategiesCross-Functional CollaborationRisk-Based Monitoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial KnowledgeSite EvaluationData Quality ManagementRegulatory CompliancePatient Recruitment StrategiesMonitoring PlansAudit ReadinessTherapeutic Area KnowledgeSafety-Event ReportingInvestigator Payments Management
Soft Skills
Interpersonal SkillsCritical ThinkingOrganizational SkillsActive ListeningPresentation Skills
Tools & Technologies
CRM ToolsMonitoring ToolsData Submission Systems
Industry Keywords
Clinical ResearchInvestigational Drug TrialsHealth-Related DisciplinesSite TrainingPatient Treatment Principles
About the role
Key responsibilities & impact- Advance AbbVie’s clinical development pipeline through excellence in clinical research
- Serve as the primary point of contact for investigative sites
- Provide contextual information on clinical trials 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, site training, routine monitoring, and site closure monitoring
- Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
- Customize site engagement strategies and track progress using CRM tools
- Apply protocol, scientific, and clinical trial knowledge to day-to-day execution
- Evaluate recruitment and retention plans based on the patient disease journey
- Develop therapeutic area, asset, clinical landscape, and patient journey knowledge
- Mentor and train less experienced CRAs
- Participate in global or local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team
- Resolve site risk signals and implement preventative and corrective action plans
- Identify and recommend investigators and sites for clinical studies
- Ensure data quality, timely data submission, and safety-event reporting
- Maintain audit and regulatory inspection readiness
- Manage investigator payments according to executed contract obligations, as applicable
Requirements
What you’ll need- Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred
- Minimum of 1 year of clinically related experience
- At least 6 months of clinical research monitoring experience on investigational drug or device trials
- Familiarity with risk-based monitoring, onsite and offsite monitoring
- Knowledge of therapeutic area indications preferred
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Strong cross-functional collaboration skills
- Strong planning and organizational skills
- Ability to work effectively in a dynamic environment with competing projects and deadlines
- Advanced ability to leverage technology, tools, and resources
- Strong interpersonal, written, verbal, active listening, and presentation skills
- Ability to establish and leverage site relationships through engagement, motivation, and training
- Critical thinking and good judgment to address clinical site issues
- Integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes
Benefits
Comp & perks- Remote work option
- Equal opportunity employment
- Reasonable accommodation for US & Puerto Rico applicants
- Employee referral opportunity