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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 regulatory standards. Possesses strong communication and organizational skills to effectively engage and train site staff and principal investigators.
Highest-signal resume keywords
Clinical Trial ManagementSite MonitoringRegulatory ComplianceRisk-Based MonitoringCross-Functional Collaboration
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 Research MonitoringProtocol ComplianceSite EvaluationRecruitment TechniquesTherapeutic-Area KnowledgeAdverse Event ReportingData SubmissionRisk AssessmentSite Engagement StrategiesInvestigator Identification
Soft Skills
Communication SkillsOrganizational SkillsInterpersonal SkillsCritical ThinkingMotivational Skills
Tools & Technologies
Clinical Trial Management SystemsMonitoring ToolsData Tracking ToolsRegulatory Compliance Software
Certifications & Qualifications
ICH/GCP Guidelines Knowledge
Industry Keywords
Clinical TrialsInvestigational Drug TrialsHealth-Related DisciplineSite Performance MonitoringPatient Safety
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Act as the primary Sponsor 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
- Conduct site evaluation, training, routine on-site and off-site monitoring, and site closure monitoring
- Develop and customise site engagement strategies
- Gather local and site insights and track engagement progress and impact
- Support day-to-day clinical trial execution and protocol compliance
- Evaluate recruitment and retention techniques and plans
- Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge
- Mentor and train less experienced CRAs
- Participate in global and local task forces and initiatives
- Conduct continuous risk assessment and monitor site performance and patient safety
- Resolve site risk signals and implement preventative and corrective action plans
- Identify and recommend investigators and clinical trial sites
- Ensure quality and timely submission of site data and safety-event reporting
- Maintain audit and regulatory inspection readiness
- Manage investigator payments as applicable
- Report adverse events within 24 hours
- Participate in WHS programs and promote a safe work environment
- Complete administrative and other ad hoc duties as requested
Requirements
What you’ll need- Appropriate tertiary qualification in a health-related discipline preferred, such as Medical, Scientific, Pharmacy, or Nursing
- Minimum 3 years of clinically related experience
- At least 2 years preferable in independent clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring and on-site/off-site monitoring
- Knowledge of therapeutic-area indications and ability to apply scientific concepts to clinical trials
- Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Advanced communication and cross-functional collaboration skills
- Superior planning and organisational skills
- Ability to work effectively in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools, and resources for 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 good judgement to clinical site issues
- Integrity consistent with AbbVie’s code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes
- Flexibility to occasionally participate in business meetings outside standard working hours
Benefits
Comp & perks- Remote work
- Flexible and accessible hiring process
- Support for accessibility requirements
- Inclusive and supportive workplace
- Occasional flexibility for business meetings outside standard hours
- Equal opportunity employment
- Workplace health and safety programs
