- Perform remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies
- Assess compliance with protocols, ICH-GCP, and applicable local and federal regulatory requirements
- Ensure patient safety and data integrity using various technologies
- Review protocols, critical data and process risks, safety risks, and data integrity risks
- Review patient data listings and visualizations to confirm eligibility and identify protocol deviations, patient safety concerns, data integrity issues, and inaccurate or missing data
- Assess factors affecting patient safety and clinical data integrity at investigator and physician sites
- Communicate and elevate serious issues to the project team and develop action plans with guidance
- Document observations and write queries, protocol deviations, or action items in appropriate systems
- Verify investigational product dispensing and administration, laboratory and other procedures, and current and complete eTMF data
- Document activity completion through tracking, reporting, and required project documents
- Manage patient- and site-level activities to meet project objectives, deliverables, and timelines
- Adapt to changing priorities with oversight from the Lead CRA/LCMDA
- Prepare for and attend investigator and sponsor meetings
- Participate in project staff meetings and clinical training sessions
Requirements
- Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements
- Good computer skills and ability to embrace new technologies
- Mastery of MS Excel, including sorting, filtering, calculating, and pivoting
- Proficiency with Analytical Data Visualization Tools, including adjusting visualizations and selecting data subsets
- Excellent verbal and written communication skills
- Ability to inform, influence, and communicate cross-functionally
- Strong analytical skills
- Developing therapeutic expertise
- Less than 10% travel, limited to trainings and investigator meetings
Core Competencies
Demonstrates expertise in clinical data review and compliance with ICH-GCP and regulatory requirements, ensuring patient safety and data integrity through effective communication and analytical skills.
Highest-signal resume keywords
- Clinical Data Review
- ICH-GCP Compliance
- Analytical Data Visualization
- MS Excel Mastery
- Verbal And Written Communication
ATS Optimization Keywords
Hard Skills
- Clinical Research
- Data Integrity Assessment
- Protocol Review
- Risk Assessment
- Data Query Documentation
- ETMF Management
- Patient Safety Monitoring
- Regulatory Compliance
- Data Analysis
- Protocol Deviation Identification
Soft Skills
- Cross-Functional Communication
- Analytical Thinking
- Problem Solving
- Adaptability
- Team Collaboration
Industry Keywords
- Good Clinical Practice
- Phase I-IV Clinical Research
- Regulatory Requirements
- Patient Data Review
- Clinical Training
Tools & Technologies
- Analytical Data Visualization Tools
- MS Excel
- ETMF Systems
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Central Monitor II Arbeitgeber: Jobtailor
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