Kyle Sumner Email & Phone Number

• Fully independent home-based monitor providing site management for Phase I-IV trial, Bioequivalence trials and device trials.• Responsible for managing multiple study sites and protocols.• Conduct Qualification, Initiation, Interim and Close-out monitoring visits in compliance with good clinical practices and FDA regulations.• Performed Risk Assessment Monitoring as well as complete, partial and remote Source Document Verification.• Maintain a positive relationship with investigators and site personnel to ensure the execution of clinical studies in a timely, efficient and effective manner. • Communicate with sponsors, sites and colleagues to ensure effective project management.• Worked with the following companies: Beaufort CRO, IND2Results, InVentiv Health Clinical, PRC Clinical, Protrials Research and Puma Biotechnology.

Slough, Berkshire Sl1 4Aa, Gb

• Fully independent home-based monitor providing site management for Phase II-IV adult, pediatric and neonate clinical trials.• Responsible for managing 4-6 protocols in the Eastern United States. • Assist the clinical study team in the implementation, conduct and reporting of clinical studies. • Conduct qualification, initiation, interim and close-out monitoring visits in compliance with good clinical practices and FDA regulations.• Maintain a positive relationship with investigators and site personnel to ensure the execution of clinical studies in a timely, efficient and effective manner. • Communicate with sponsors, sites and Clinimetrics colleagues to ensure effective project management.

• Office based monitor responsible for the identification of qualified investigators, manage protocol and CRF development in collaboration with study team, establish and periodically review data handling standards, and assist project manager with the evaluation of studies by reviewing study data and resolving data queries. • Conduct initiation, monitoring and study termination visits in compliance with good clinical practices and FDA regulations.• Tracked study metrics, monitored clinical data collection and facilitated study related issues between principal and sub-investigators, nurses and other medical professionals.

• Provided leadership for implementing all aspects of multiple and concurrent Phase II-IV clinical trials. Responsibly for the successful execution and completion of 3-5 protocol.• Performed patient recruitment and enrollment, following GCP guidelines and FDA regulations.• Supervised two other study coordinators, including training and ensuring protocol compliance.• Processed regulatory documentation and IRB correspondence and prepared for site initiation, monitoring and close-out visits by CRAs.