Attention to Detail
Applies mental focus to their duties to ensure that work is accurate and error free and consistently pays attention to detail to ensure consistency of work and results to improve decision-making and achieve results or accomplish tasks/objectives.
Collaboration
Works effectively with others to foster trust and cooperation in the achievement of R&D goals and project objectives.
Communication
Employs fundamental methods to communicate effectively in writing and verbally within the trial and site teams to ensure understanding and enhance team and personal performance.
Digital Technologies Proficiency
Proficiently uses and trains site staff in the digital technologies and software applications used for clinical trials.
Monitoring
Follows the risk-based monitoring plan and applicable study requirements and standards to carry out all required monitoring-related responsibilities to protect participants’ safety and well-being and maintain the integrity of clinical trial data.
Organization
Applies organizational skills to plan, prioritize, track and complete required tasks within time restraints.
Quality Assurance
Through clinical monitoring, ensures that site teams are using verifiable processes and conducting all study-related activities in compliance with the study requirements, local SOPs, ICH GCP, local/central REB requirements and applicable regulatory requirements.
Regulatory Compliance Verification
Uses best practices in clinical monitoring to verify and ensure that site teams are conducting clinical trials according to all applicable ethics and regulatory requirements.
Source Data Verification
Critically reviews the original source documentation and compares it to what has been entered into data collection tools in a risk-based manner according to the risk-based monitoring plan to ensure that the clinical data is complete, accurate and verifiable as per the study requirements.
Study Document Management
Monitors that the sites follow document control procedures to ensure that the trial processes are verifiable and that the integrity of the trial processes and results are maintained.
Teamwork/Collaboration
Applies sound teamwork processes to foster cooperation and collaboration across diverse stakeholder groups, enabling effective and efficient project execution and fostering a shared approach to project success.
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