Essential Functions
• Develop and implement CRA training program to enhance clinical monitoring skills
• Assess CRA performance and identify areas for improvement through competency evaluations
• Ensure CRA compliance with GCP and Regulatory requirements
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employee, and addressing employee relations issues and resolving problems.
• Ensure that new employees are properly onboarded and trained.
• Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
• Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
• Continuously assess and recommend process improvements to enhance CRA compliance with performance metrics.
• Provide hands-on training and feedback to improve monitoring skills and evaluate the impact of the feedback.
• Share CRA performance feedback with DLM and contribute to customized development plans for performance improvement.
• Develop a structured training program focused on on-site monitoring best practices.
• Ensure staff have the necessary materials, system access, and training to perform their responsibilities effectively.
• Accompany CRAs to investigator sites for monitoring activity
Qualifications
• Minimum of 4-5 years of experience as CRA in the CRO or pharmaceutical.
• Develop and implement CRA training program to enhance clinical monitoring skills.
• Prior experience in CRA coaching or Lead CRA is required.
• Assess CRA performance and identify areas for improvement through competency evaluations
• Ensure CRA compliance with GCP and Regulatory requirements
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com