PI: Haydar FrangoulPrimarily working on CRISPR gene editing and pediatric oncology clinical trials- Received training to provide coverage for Clinical Research Coordinators- Compiled data points for metrics reporting with site manager- Continued to complete all responsibilities of Data Coordinator role

PI: Haydar Frangoul, MDPrimarily working on CRISPR gene editing and pediatric oncology clinical trials- Improved system for maintaining training records for sixty clinical trials for ease of access for all team members and better organization- Utilized Microsoft Office suite to create templates and trackers for necessary study information- Championed project to equip our site with capabilities of performing required scan types- Reviewed processes in place and worked to update SOPs and WIs to suit evolving needs of growing team- Trained new employees in the Data Coordinator role on all essential tasks for job functions while completing tasks for multiple roles until new hire training was completed- Worked closely with the Quality Assurance department to prepare for FDA, sponsor, and internal audits- Communicated with study sponsor personnel concerning data and upcoming visits- Prepared for and hosted on-site monitoring visits - Maintained up to date regulatory filings and patient charts for all assigned clinical trials and patients- Sent required trainings for all studies when onboarding team members and ensured access to all systems necessary for job functions was granted- Served as a primary contact between site and sponsor; coordinated communication and correspondence; ensured timely transmission of clinical data with the study sponsors and technical reporting as requested.- Reviewed quality and integrity of data through entry of electronic CRF data and working with sponsor to resolve queries.- Documented accountability, stability, and storage conditions of clinical trial materials as required by sponsor. - Performed investigational product and research lab kit inventory and prepared research kit for patient visits and shipped samples on visit date.

- Built relationships with course instructors to ensure planned sessions for the week were in line with learning objectives- Prepared and submitted weekly lesson plans and activities for three to four one-hour group tutoring sessions per week- Attended training once per semester focused on session planning and professional development