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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 ICH/GCP Guidelines. Possesses strong interpersonal and organizational skills to effectively engage and train site staff and investigators.
Highest-signal resume keywords
Clinical Research MonitoringICH/GCP GuidelinesSite 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 ProtocolsSite EvaluationOnsite MonitoringOffsite MonitoringRegulatory CompliancePatient Recruitment TechniquesData SubmissionSafety-Event ReportingClinical Landscape KnowledgeTherapeutic Area Indications
Soft Skills
Interpersonal SkillsOrganizational SkillsCritical ThinkingSelf-MotivationActive Listening
Tools & Technologies
Site Engagement ToolsMonitoring PlansTechnology Resources
Industry Keywords
Oncology Clinical ResearchInvestigational Drug TrialsClinical Site ManagementRegulatory Inspection ReadinessAbbVie SOPs
About the role
Key responsibilities & impact- Advance AbbVie’s oncology clinical research pipeline and turn science into medicine
- Partner with study teams, internal R&D stakeholders, investigators and site staff
- Serve as the primary Sponsor 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 onsite and offsite monitoring, and site closure monitoring
- Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs and quality standards
- Develop and customize site engagement strategies and track progress and impact using site engagement tools
- Apply clinical trial protocols and scientific principles to day-to-day trial execution
- Evaluate recruitment and retention techniques based on the patient disease journey
- Build therapeutic-area, asset, clinical-landscape and patient-journey knowledge to support recruitment and protocol compliance
- Mentor and train less experienced CRAs and contribute to their development
- Participate in global or local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team to identify study performance or patient safety issues
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate and recommend new investigators and clinical sites
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up
- Maintain audit and regulatory inspection readiness at assigned clinical sites
- Manage investigator payments according to executed contract obligations, as applicable
Requirements
What you’ll need- Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy)
- Valid driver’s license
- Minimum of 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, onsite monitoring and offsite monitoring
- Knowledge of appropriate therapeutic area indications and ability to apply scientific concepts to clinical trials
- 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
- Ability to leverage technology, tools and resources for customer-centric site support
- Strong interpersonal, written, verbal, active listening and presentation skills
- Ability to establish site relationships and trusted partnerships through engagement, motivation and training
- Critical thinking and good judgment to address clinical site issues
- Integrity in accordance with AbbVie’s code of business conduct and leadership values
- Self-motivation and focus on timely, quality outcomes
- Willingness to travel 75% of the time
Benefits
Comp & perks- Life assurance
- Medical plan
- Flexible benefits
- Company car
- Comprehensive total reward package including compensation, well-being and benefits
- Coverage under the B011 – CCNL Chemical-Pharmaceuticals Industry national collective bargaining agreement