Blessing Simon Email & Phone Number

• Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.• Trains site staff on the EDC system and verifies site computer system.• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.• Works with sites to resolve data queries.• Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.• Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.• Attends study-related, company, departmental, and external meetings, as required.• Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.• Ensures all study deliverables are completed per IQVIA Biotech and study timelines

Key Responsibilities: • Conducted monitoring visits (ISEV, ISIV, IMV & COV).• Completed Confirmation letters, Monitoring reports, DRLs, Follow up letters per company guidelines.• Managed assigned sites and ensured proper protocol understanding and compliance• Reconciled investigational products on-site and processed drug shipment to depot as applicable.• Source verified subject data and ensured all AEs, SAEs, AESI are reported• Ensured sites have applicable regulatory approvals• Reviewed and ensured subjects were properly consented prior to study participation• Ensured assigned sites complied to ALCOA-A principles• Trained sites during SIVs and re-trained as necessary• Ensured accuracy and completeness of the data in CRFs and resolution of data queries.• Reported trends and observations noted at sites to study team.