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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 monitoring, ensuring compliance with ICH/GCP Guidelines and federal regulations while effectively managing clinical sites and personnel. Proficient in training site staff and maintaining regulatory inspection readiness.
Highest-signal resume keywords
Clinical Trial MonitoringICH/GCP Guidelines ComplianceSite Qualification and InitiationRegulatory Inspection ReadinessMicrosoft Office Suite Proficiency
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 Monitoring ExperienceInvestigational Drug TrialsData DocumentationSafety-Event ReportingStudy Closeout VisitsProtocol ExecutionAction Plan ImplementationTherapeutic Indications KnowledgeSite Personnel ManagementNegotiation Skills
Soft Skills
Strong Planning SkillsOrganizational SkillsInterpersonal SkillsAnalytical CapabilitiesEffective Communication
Tools & Technologies
Microsoft Office SuiteMonitoring PlansSOPsClinical Trial Management Systems
Industry Keywords
Clinical ResearchGood Clinical PracticeFederal RegulationsStudy MonitoringPhase I to III Studies
About the role
Key responsibilities & impact- Proactively solve study-related clinical site issues and initiate, recommend, and communicate corrective action
- Monitor activities conducted by clinical investigative sites for successful protocol execution
- Ensure adherence to federal and local regulations, GCPs, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards
- Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase I to III studies
- Oversee site personnel activities and motivate/influence them to meet study objectives
- Proactively manage sites and implement action plans to ensure compliance
- Ensure regulatory inspection readiness at assigned clinical sites
- Ensure quality and timely submission of study-site data, including safety-event reporting and follow-up
- Ensure safety and protection of study subjects through monitoring-plan, SOP, guideline, and regulatory compliance
- Train study-site personnel on protocols and regulatory requirements
- Manage investigator payments according to executed contract obligations
- Negotiate investigator/hospital agreements with stakeholders
- Complete expense reports according to local and applicable guidelines
- Identify, evaluate, and recommend new/potential investigators and sites
Requirements
What you’ll need- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred
- Minimum of 2 years of clinically-related monitoring experience
- Experience in on-site monitoring of investigational drug or device trials is required
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations
- Familiarity with all aspects of study monitoring; data, drug accountability, documentation experience
- Strong planning and organizational skills and ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Ability to work, understand and follow work processes within the assigned function
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity
- Ability to address study related clinical site issues with appropriate guidance and initiate and communicate corrective action as indicated
- Ability to use functional expertise and exercise good judgment
- Demonstrated business ethics and integrity
- A minimum of 50% travel is required
- Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)
- Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks)
- Valid driver’s license and passport
Benefits
Comp & perks- Innovative work culture
- Professional development
- Paid time off: vacation, holidays, personal days, and volunteer days
- Employee stock purchase
- Wellness spending account
- Flexible health insurance
- Retirement savings programs
- Bonus plan