Danny O.

• Provided oversight of CRA monitoring activities, including review and approval of site visit reports to ensure compliance with study plans, SOPs, GCP/ICH, and regulatory requirements. • Conducted quality co-monitoring visits to evaluate CRA performance, identify risks,and implement corrective preventive actions. • Served as the lead site management contact for assigned studies, maintaining timely conducted site training on gene therapy trials targeting NSCLC and SCLC using biologics via lipid nanoparticle delivery systems (TUSC2) protocols, including proper handling and testing procedures, to support biomarker-driven oncology and rare disease studies. • Monitored gene therapy studies involving REQORSA®, a biologic used in subjects with NSCLC and SCLC. • Reviews study-related and essential clinical study start-up documents (e.g., Informed consent forms, Monitoring Plan, Patient Eligibility Form, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters. • Support Clinical Operation team with conduct UAT on several Vendor systems.

• Promoted from CRA II to Senior CRA I following Luzsana Biotech's acquisition of Hengrui USA. • Reviewed CRA deliverables for consistency and quality; provided feedback and CAPAs when necessary. • Supported project management in site performance oversight, including recruitment strategies, site payments, and study supply needs. • Coordinated cross-functional review of training materials and supported regulatory submissions. • Led Managed oncology and early-phase biologic studies including site initiation,qualification, and monitoring. • Responsible for site communication and management. • Report all Adverse Events and Serious Adverse Event(SAE) according to study timelines. • Collaborated with cross-functional teams to align site-specific diagnostic activities with study protocols and therapeutic objectives. • Support regulatory team in preparing documents for study submissions. • Ensure integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

• Ensure the protection of study patients by verifying informed consent procedures and protocol requirements is adhered to according to the applicable regulatory requirements. • Ensure Safety Reporting and compliance for adverse event reporting. • Responsible for site communication and management. • Report all Adverse Events and Serious Adverse Event (SAE) according to study timelines. • Communicate with internal project teams regarding study progress. • Support regulatory team in preparing documents for study submissions. • Ensure integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. • Monitor data for missing or implausible data. • Ensure resources of the Sponsor and company is spent wisely by performing the required monitoring tasks in an efficient manner according to SOPs and established guidelines, including managing travel expenses in an economical way according to company’s travel policy. • Prepare accurate and timely trip reports. • Develops strong, collaborative investigational site relationships and ensures continuity of relationships through all stages of the trial.

• Develops strong, collaborative investigational site relationships and ensures continuity of relationships through all stages of the trial. • Performs clinical study site management/monitoring activities efficiently in compliance with the approval protocol, FDA/GCP/ICH requirements, SOPs, local laws and regulations, protocol, Clinical Monitoring Plan, and associated documents. • Demonstrates an in-depth understanding of the study protocol and related procedures. • Participated and provides input on site selection and site qualification activities. • Coordinates and manages various tasks in collaboration with the study team to achieve site activation. • Performs remote and on-site monitoring activities using various tools to ensure subject rights, safety and well-being are protected as well as the reliability and integrity of study data. • Conducts site visits including but not limited to qualification visits, initiation visits, interim monitoring visits, close-out visits, and generates clear, comprehensive, and accurate visit reports and letters in a timely manner. • Monitor investigator sites with a risk-based approach: apply root cause analysis (RCA), critical thinking and problem-solving skills to identify site process failures and corrective/preventive actions to bring the site into compliance and decrease risks. • Reviews and verifies study records including source documents, case report forms, informed consent forms and other materials to ensure data is complete and accurate. • Manages and maintains visit information such as site/subject visit tracking and other documentation in Clinical Trial Management System (CTMS), Trial Master File (eTMF) and various other systems per study timelines

• Conducted site qualification, initiation, monitoring, and close-out visits. • Established regular lines of communication plus administering protocol and related study training to assigned sites. • Evaluated site practices for compliance and escalated quality issues when identified. • Managed regulatory submissions, recruitment progress, CRF completion, and data query resolution. • Provided training to site staff on study protocols and safety reporting. • Assisted Senior CRAs and CRA-II with on-site tasks as required and according to training goals (e.g., review of Case Report Forms and drug accountability). • Assisted with the administration of clinical research projects, collecting investigator documentation and site management. • Ensured protection of study patients by verifying that informed consent procedures and protocol

• Established regular lines of communication plus administering protocol and related study training to assigned sites. • Evaluated quality and integrity of site practices, escalating quality issues as appropriate. • Managed progress by tracking regulatory submissions, recruitment, case report form (CRF) completion and data query resolution. • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance. • Responsible for aspects of registry management as prescribed in the project plans. • Assisted Senior CRAs and CRA-II with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and drug accountability). • Ensured study staff conducting protocol receive proper materials and instructions to safely enter patients into the study. • Ensured protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. • Assisted with the administration of clinical research projects, collecting investigator documentation and site management. • Updated, tracked, and maintained study-specific trial management tools/systems. • Generated and tracked drug shipments and supplies. • Tracked and followed-up on serious adverse events.

• Attend internal meetings and prepare team agendas and minutes. • Tracking and summarizing results of these activities. • Track and file confidentiality agreements with sites. • Work with Regulatory Affairs Specialist to update tracking, naming, and filing of site essential regulatory documents. • Maintain correspondence lists for sites • Prepare and compile study related materials • Obtain, review, and process regulatory and administrative documents. • Review investigator site files to ensure all documentation is complete and up to date. • Resolve issues, questions, and process requests for additional study supplies. • Review Tables and Listings generated from study data.

• Collected data, source documentation, completed study specific case report forms and submitted adverse experience reports. • Assisted Principal Investigator on all studies. • Coordinated and ensured execution of all clinical study protocol activities within Good Clinical Practice (GCP) and the Food and Drug Administration (FDA) regulations and requirements. • Ensured execution of Sponsor expectations and Standard Operating Procedures (SOPs). • Supported patient enrollment onto clinical trials through recruitment, screening and follow up of eligible subjects according to protocol requirements. • Ensured the integrity of the data submitted on Case Report Forms or other data collection tools. • Ensured that adequate and accurate records were maintained for inspection. • Created study specific tools for source documentation. • Collected, completed, and entered data into study specific case report forms or electronic data capture systems. • Generated and tracked drug shipments and supplies as needed.