Amy Ndukwo

• 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. • First point of contact when investigators/site personnel enquired about a patient. inclusion/exclusion criteria for ongoing trials. • Serves as primary contact for internal clinical monitoring study team members, external Vendors, and clinical sites. • Participation in Regional Clinical Operations meetings, representing the country’s interests and perspective. • Organized investigator's start-up meeting and study site initiation meetings. Collaborate with the assigned clinical project team to ensure objectives are met. • 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. • Perform clinical study site management/monitoring activities in accordance with (ICH- GCP) International Conference on Harmonization Good Clinical Operating, Standard Operating Procedures (SOPs), Local Laws &Regulations, Protocol, and Site Monitoring Plan. • Ensure the Subject’s rights, safety, and well-being are protected. • Provide support to plan Investigator Meeting presentations, data collections, and FDA submissions. • Coordinate work activities to save time and remain within budgetary guidelines. • Conducts and/or oversees all aspects required for selecting, initiating, monitoring, and closing investigational sites in accordance with all applicable SOPs and GCP/ICH requirements. • Responsible for CRO selection and oversight (local outsourcing of monitoring activity) and collaboration with CRO at the country level (in centrally outsources trials) -Shadowed

• Prepared accurate and timely trip reports. • Identified and completed follow-up of SAEs at the study site for which he/she is responsible. • Independently performed 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. • Ensured that Site Regulatory Documents are complete and current throughout the duration of the trial. • Performed Project Plans related to Clinical Monitoring responsibilities and administrative documents as related to clinical research functions. • Lead and sign off other CRAs to ensure the quality of clinical monitoring and site management deliverables. • Prepare site visit reports, key issues for resolution, and recommendations for follow-up actions for assigned study sites.

• Responsible for the management of assigned clinical trial sites. • Organized investigator's start-up meeting 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. • Conduct site qualification, site initiation, interim monitoring, and close-out visits. • Develop and maintain the site and investigator relationships to manage clinical trials 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.

• Responsible for performing vital signs, height, weight, and ECG’s • Analyzed subject data in relation to 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 • Familiarized with FDA Regulations pertaining to clinical trials. • Responsible for assisting with the recruitment of potential subjects for appropriate studies and redirects as needed based on study criteria. • Responsible for facilitating initial visits with study subjects. • Screened patient records, databases, and physician referrals to identify prospectively candidates for research studies