Silvio Resuli Email and Phone Number

• Responsible for implementation of Clinical Conductor CTMS and eSource solutions. • Manage team of 23+ departmental process owners throughout the multi-sustem, multi-national data transfers.• Create data management protocols, data management plans, and data templates for cloud-based operations. • Lead study build, user management, access management, and central study deployment processes.• Review SQL data migration options and own data transformation between legacy and new systems.

• Remote CRC managing all non-patient facing CRC procedures, including Sponsor and CRO communication.• Create and maintain study in CRIO/CTMS from protocol to source, including conducting end-user testing.

Subjects/Software: Research Methods, Scientific Writing, SPSS, R, SQL, Microsoft Access.• Provide project-based assistance for data-based clinical research inquiries.• Assist clients in formulating and operationalizing their studies and data collection.• Prepare data for analysis, ensure data integrity through queries and validity checks. • Conduct the appropriate statistical analyses and report the results in visual and written form.

• Managed activities and regulatory compliance for a phase IV, pharmaceutical post-marketing surveillance study. • Conducted quality assurance and re-retraining activities based on EDC and Protocol requirements. • Managed vendor payments and Sponsor special data requests.• Oversaw regulatory submissions and compliance with electronic Trial Master File. • Assisted PI and Project Manager with manuscript preparation and submission.

• Lead CRC in three studies in phases II and III.• Presented ICF in English and Spanish to subjects of age and minors. • Performed visit activities, including soliciting medical history, ECG, blood draw and processing, buccal swab, etc.

• Managed daily activities and compliance for 40+ patients in 3 neurological trials (2 phase III & 1 device study).• Created source documents and electronic databases according to ICH GCP and HIPAA guidelines.• Between April and July 2017, I worked as a remote Consulting CRC for the Boston Center for Memory. During this time, I assisted with patient scheduling, billing, regulatory compliance, and data quality control.

• Devised recruitment and retention of 156 participants across 6 months in Massachusetts and Puerto Rico. • Prepared budget and IRB application.• Administered assessments and entered data; designed and maintained databases.• Prepared and presented findings during the APS Conference in May 2019.