Faith W.

• Ensure clinical trials are conducted in compliance with protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries and sites • Ensure subject safety and verify diligence in protecting the confidentiality and wellbeing of study subjects • Verify adequacy, completeness, reliability, and quality of trial data collected at study sites • Conduct site qualification, site initiation, interim monitoring and close out visits • Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently. • Participate in the evaluation of potential clinical sites according to established criteria of acceptability. • Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. • Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. • Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. • Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. • Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. • Assist with the maintenance of clinical archive and electronic files.

• Monitored assigned clinical trials following company SOPs and in accordance with GCP. • Maintains integrated timelines with all discipline deliverables), monitoring, site management, trial master files, and clinical research associate performance. • Communicate with Investigators and site staff on issues related to protocol conduct, retention, protocol deviations, regulatory documentation, site audits/inspections, recruitment, and site performance. • Mentor Junior CRAs on study requirements and perform co-monitoring visits. • Operating Procedures (SOPs), Local Laws & Regulations, Protocol, and Site Monitoring Plan. • Provide support to plan Investigator Meeting presentations, data collections, and FDA submissions.

• Monitored assigned clinical trials following company SOPs and in accordance with GCP. • Maintains integrated timelines with all discipline deliverables), monitoring, site management, trial master files, and clinical research associate performance. • Communicate with Investigators and site staff on issues related to protocol conduct, retention, protocol deviations, regulatory documentation, site audits/inspections, recruitment, and site performance. • Mentor Junior CRAs on study requirements and perform co-monitoring visits. • Operating Procedures (SOPs), Local Laws & Regulations, Protocol, and Site Monitoring Plan. • Provide support to plan Investigator Meeting presentations, data collections, and FDA submissions.

•Responsible for the management of assigned clinical trial sites. • Organized investigator's start-up meetings and study site initiation meetings. • Coordinated the movement of laboratory samples and the resulting data when central laboratory facilities are used. • Ensured procedures are in place for the appropriate optimization of patients in the clinical trial. • Monitored assigned clinical trials following company SOPs and in accordance with GCP. • Responsible for the management of assigned clinical trial sites. • Assist in study start-up and recruitment for sites assigned. • Verify adequacy, completeness, reliability, and quality of trial data collected at study sites.

•Prepared accurate and timely trip reports. • Identified and completed follow-up of SAEs at the study site for which he/she is responsible. • Independently perform CRF review, query generation, and resolution against established data review guidelines on CTMS. • Confirmed study staff conducting the protocol have received the proper materials, instructions, and training to safely enter subjects into the study and complete the protocol requirements. • Ensured subject protection by verifying that informed consent procedures and protocol requirements are adhered to according to regulatory requirements. • Ensured the integrity of the data submitted on CRFs or other data collection tools by careful source document review.

• Responsible for performing vital signs, height, weight, and ECGs. • Analyzed subject data in relation to the study protocol for entrance into the study. • Educated and provide information to study subjects, families, and clinical staff members regarding clinical drugs trials. • Coordinated scheduled visits and adherence to visiting windows. • Completed final subject visit and the follow-up study protocol. • Ensured strict adherence to study protocol and accurate completion of all study-related documentation. • Familiar with FDA Regulations pertaining to clinical trials. • Responsible for assisting with recruiting potential subjects for appropriate studies and redirecting as needed based on study criteria. • Responsible for facilitating initial visits with study subjects. • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.