Ade Adewuyi

• Monitor the assigned clinical trial sites to ensure that study is conducted according to the protocol, FDA regulations, ICH guidelines, Good clinical practice (GCP), HIPAA, all applicable SOP’s, and project guidelines. • Identify early on any unsatisfactory results, operations or specific problems and take immediate action to appropriate groups including escalating and assisting in resolving any study related issues that arise during study conduct. • Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits. • Collect and review site regulatory and essential documents for accuracy and completion. • Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained • Accountable for data integrity, patient safety and regulatory compliance for all assigned sites. • Assist the project management team in identifying risks in study execution at study sites, implement mitigations, monitoring outcomes, and communicate observations. • Perform source document verification during monitoring visits and ensure site is adhering to the protocol in subject enrollment target, and general study conduct. • Ensure that investigational drug is stored according to the pharmacy manual and that subjects are dosed according to the protocol. • Account for all drugs shipped to the site and ensure that all unused and expired drugs are returned back to the sponsor or destroyed at the site per the drug handling instructions.

• Perform all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits. • Lead and manage multiple internal cross-functional teams to ensure the effective delivery of assigned project milestones. • Train investigator(s) and site staff on study protocol and all relevant study procedures • Review CRA reports and provide feedback to ensure highest possible standards are met • Monitored CRO and vendor activities by reviewing meeting minutes, trackers, and reports; followed up on deliverables and performance metrics. • Performed first-pass invoice review from sites and vendors and supported accrual generation and reconciliation with finance teams. • Perform Source Data Verification (SDV) and data cleaning in accordance with study monitoring plan. • Maintain and Restructure TMF to meet highest quality standard in preparation for an Audit. • Supported study start-up activities and vendor setup specifications; collaborated directly with sites, CRAs, and CROs to collect updates and drive trial progress. • Participated in clinical team meetings, investigator meetings, and vendor meetings including note-taking and action item tracking. • Collected, tracked, and conducted initial review of regulatory documents to ensure completeness for device release and TMF/eTMF filing. • Assist and/or develop study-related plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, informed consent forms, monitoring plan, etc. • Utilized EDC and CTMS systems to generate data reports, monitor enrollment and query metrics, and ensure data quality. • Coordinated submission and updates of ClinicalTrials.gov with timely communication to the CTM regarding changes to site status and trial progress.

• Monitor the assigned clinical trial sites to ensure that study is conducted according to the protocol, FDA regulations, ICH guidelines, Good clinical practice (GCP), HIPAA, all applicable SOP’s, and project guidelines. • Attend Investigator Meetings and other study-specific training for assigned trials. • Evaluate clinical trials to identify qualified sites for selection for planned investigational studies. • Conduct initiation visits and ensure that site has received all essential study supplies for clinical studies. • Perform source document verification during monitoring visits and ensure site is adhering to the protocol in subject enrollment target, and general study conduct. • Ensure that investigational drug is stored according to the pharmacy manual and that subjects are dosed according to the protocol. • Managed clinical tracking tools, including spreadsheets for subject enrollment, essential documents, investigational product, and lab sample tracking. • Account for all drugs shipped to the site and ensure that all unused and expired drugs are returned back to the sponsor or destroyed at the site per the drug handling instructions. • Develops and maintains collaborative working relationships with clinical investigative sites. • Accountable for data integrity, patient safety and regulatory compliance for all assigned sites. • Demonstrate understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites. • Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. • Responsible for timely reporting of AEs/SAEs and protocol deviation. • Resolved site monitoring issues, followed up on visit reports, and tracked outstanding action items to ensure continuous compliance.