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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 monitoring, including risk-based monitoring and compliance with ICH/GCP Guidelines. Possesses strong interpersonal and organizational skills to effectively engage with stakeholders and manage clinical trial operations.
Highest-signal resume keywords
Clinical Research MonitoringRisk-Based MonitoringICH/GCP GuidelinesCross-Functional CollaborationSite Relationship Management
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 ExecutionSite EvaluationPatient Recruitment TechniquesRegulatory ComplianceData SubmissionTherapeutic Area KnowledgeMonitoring TechniquesQuality StandardsAudit ReadinessSafety-Event Reporting
Soft Skills
Interpersonal SkillsOrganizational SkillsCritical ThinkingActive ListeningPresentation Skills
Tools & Technologies
CRM ToolsMonitoring SoftwareData Tracking Systems
Industry Keywords
Clinical ResearchInvestigational TrialsHealth Related DisciplinesPatient JourneySite Staff Training
About the role
Key responsibilities & impact- Advance AbbVie's clinical research pipeline by striving for excellence in clinical research and leveraging advanced capabilities
- Partner with investigators and site staff to support meaningful clinical-trial engagements
- 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 in compliance with protocols, regulations, GCP, ICH Guidelines, SOPs and quality standards
- Customize site-engagement strategies and gather local/site insights using CRM tools to track progress and measure impact
- Connect study protocols, scientific principles and clinical-trial requirements to day-to-day trial execution
- Evaluate recruitment and retention techniques based on the patient disease journey
- Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge to support recruitment and protocol compliance
- Mentor and train less experienced CRAs and provide development input
- Participate in global/local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team to detect study-performance or patient-safety issues
- Resolve site-risk signals and implement preventative and corrective action plans
- Identify and evaluate potential investigators and sites
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up
- Maintain audit and regulatory inspection readiness
- Manage investigator payments 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, including 6 months in clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications preferred
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Strong cross-functional collaboration skills among internal and external stakeholders
- 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 for customer-centric site support
- Strong interpersonal, written, verbal, active listening and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation and training
- Ability to apply critical thinking and good judgment to address clinical site issues
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes in a fast-paced environment
Benefits
Comp & perks- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community
