Sofia Velasco Email & Phone Number

Durham, North Carolina, Us

Durham, North Carolina, Us

Burlington, North Carolina, Us

Wilmington, Nc, Us

Wilmington, Nc, Us

-Centralized Report Review • Implement efficiency in visit report review• Performing a more cost-effective approach with new quality steps to the report review process, giving consistency across regions/projects • Timely follow-up to ensure compliance with report finalization timelines• Relieve CTM time to cover other tasks: Enabling more effective project oversight and Management of RBM and AIM processes.

Switzerland 🇨🇭 , Ch

Responsible as CTM for LATAM studies for country feasibility, country projects compliant, data management deadlines goals accomplishments, financial contracts, regulatory ICH/GCPs study documentation adaptation for countries, region and country recruitment goal targets. Prepared and executed presentation of project specific and therapeutic training to clinical project teams, participated in Project Team Review meetings to communicate progress of studies, quality issues, and operational concerns. Perform, and coordinate pre-study meetings, Investigator´s Meetings, review CRA reports, participation with CROs follow up by Sponsor for studies fully contracted or partially contracted for monitoring, close out studies eCRF data cleaning for the region.

Switzerland 🇨🇭 , Ch

Worked on more than 30 Clinical trials in different Therapeutic areas: Cardiovascular, Endocrine/Metabolic, Musculoskeletal and Respiratory. Gained significant experience in diabetes studies in clinical trial phases II-IV as CRA and in oncology studies as Regional Project Manager. Performed all types of Monitoring Visits: PSV, SIV, IMV and COV. Worked in Feasibility departments.Used different Clinical and/or client specific systems for trial management, such as EDC, CTMS, IVRS, IWRS, eDiaries. Performed 100% or reduced SDV, on-site and remote visits.Familiar with AIM methodology and trained in Risk Based Monitoring.Trained in various Therapeutic areas including, Oncology and Endocrinology

• Monitoring of the clinical research sites in México, in compliance to the local regulations and sponsors SOPs.• Regulatory management at site level for Phase II and Phase III Clinical Research Trials.• Accuracy, completeness, and compliance review of the information obtained during the clinical trials.• Support to the clinical research sites for the proper projects execution.• Patient recruitment support and patient’s selection support.

Wilmington, Nc, Us

Lomas De Reforma, Distrito Federal, Mx