• Primary contact for external CRAs• Review Clinical Monitoring Plans and source document templates from clinical sites• Manage RFPs for clinical sites and vendors• Train external CRAs on study protocol specifics and maintain training documentation• Manage protocol deviations and escalate safety queries• Participate in QA audits of clinical sites

• Contracted via ProClinical• Consulted management on study-start up procedures in a Phase 1/2 neuro medtech start-up environment• Consented patients to investigational device exemption (IDE) studies and provide trial education via telehealth• Conducted remote patient visits and protocol neurological motor assessments, and review daily patient concomitant medications and adverse events (AE), and escalate changes from baseline symptoms• Audited source documents and case report forms (CRF) according to ALCOA standards and regulatory compliance• Wrote protocol deviations, AEs, and answered queries within study timeline to assure clinical trial milestones are met—including study close out• Oversaw the execution of monitoring plans, preparing reports, and resolving site issues• Generated query reports and assigned about 5 team members to resolve documentation and site issues

• Contracted via Vitalief• Monitored and verified clinical research data, including ICF, subject enrollment, study visits, IP accountability, pill diaries, lab manual, protocols, regulatory forms and trial supplies• Reviewed Serious Adverse Events (SAE), deviations, and other safety reports, e.g.: CAPA and SUSARs, and reported site updates to internal admin, Sponsors, vendors, and appropriate regulatory, lab, and project management teams• Led new protocol study-start up, delegated task lists to about 6 direct reports (research coordinators, data support staff, lab personnel, clinical research nurses, regulatory) and motivated small teams to assure study milestones are met• Triaged queries, raised protocol inconsistencies, and created and quality assured internal docs, e.g.: eligibility checklist• Served as site subject matter expert coordinating about 5-8 sponsor-dedicated protocols, and liaison to vendors and CROs

• Consented patients for non-therapeutic studies, e.g.: future biomedical banking, genetic testing, pre-screening survey• Monitored on-site patients of Phase IV investigator-initiated trials (IIT) and verified completion of protocol assessments• Scheduled timepoint-specific assessments including radiological scans, specimen collection orders, and doctor visits• Facilitated neuro cognition tests and collected real-world evidence (RWE) for a GI study via administration of quality-of- life questionnaires (QOL) and the gathering of familial history• Processed and shipped research specimens as per IATA

• Monitored and interpreted cardiac telemetry rhythm readings in an inpatient setting, e.g.: Cath Lab, ER, CVICU, Obs., Endo• Audited and quality checked (QC) vendor Holter monitors and protocol-specific electrocardiogram (EKG) machines• Entered orders (in vitro diagnostics (IVD, bloodwork), EKGs, scans, vital signs, external consults) and assisted the collection of routine assessments (intravenous (IV) access phlebotomy, EKGs, i-STAT, glucose, urine and saliva specimens)• Documented data (telemetry readings, specimen collections, vital signs) into electronic data capture system• Provide technology training and troubleshoot support, and ensure unit system accesses and sufficient supplies on site• Recipient of the DEC 2020 Hero of the Month Award for early detection of deadly rhythms in two patient cases