Manages and monitors the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution. • Executes project plans, budgets, monitoring visits, schedules, and trainings. • Provides expert level recommendations on data analysis, research, and public health. • Drafts, edits, and ensures proper facilitation of presentations, training initiatives, study policies and procedures for the Sponsor, and additional stakeholders. • Develops corrective action preventive action (CAPA) plans to assess risk and appropriate mitigation strategies. • Assists with the creation and development of policies to ensure all sites are following applicable standardization requirements. • Conducts scientific and clinical studies to support the development of public health initiatives to decrease disease, disability, and health disparities. • Reviews site budgets, in conjunction with finance, site marketing, legal documents, with applicable team members to ensure contracts are completed prior to study procedures. • Perform investigational product inventory reconciliation and ensure return of unused investigational product to designated location or verify destruction as required. • Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits. • Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits. • Measures and analyzes data outcomes to support public health initiatives, and treatment of diseases. • Consistently evaluates, and reviews regulatory products, regulations, guidance documents, SOPs, involving high level and sensitive data.

• Supervised project advancements to ensure the production of high-quality deliverables while optimizing efficiency. • Reviewed contracts and delivered contract awards to selected sites for study participation. • Executed project plans, budgets, contracts, monitoring visits, schedules, and trainings. • Prepared scientific reports, trainings, and clinical presentations to present and educate study team, clinical site staff, in conjunction with study protocol. • Provided clinicians with relevant statistical data to facilitate clinical trials and inform disease prevention, screening, diagnosis, and treatment methods. • Assisted with the creation and development of policies, contracts, cost-price analysis, to ensure all sites are following applicable standardization requirements. • Analyzed and developed ideas for implementation of new study policies and procedures. • Reviewed and interpreted investigational product/drug/device manuals, protocols, policies, and SOPs, that were subject to Federal regulations. • Conducted scientific and clinical studies to support the development of public health initiatives to decrease disease, disability, and health disparities. • Adhered to drug storage protocols and standard operating procedures (SOPs) to maintain compliance.

• Collaborated closely with principal investigators and Biotech sponsors to streamline daily trial operations and ensure adherence to project protocols. • Reviewed site budgets, in conjunction with finance, site marketing, legal documents, and applicable team members to ensure contracts were completed prior to study procedures. • Conducted thorough screening of patient records, databases, and physician referrals to identify potential candidates for research studies. • Reviewed and interpreted investigational product/drug/device manuals, protocols, policies, and SOPs, that were subject to Federal regulations. • Developed and executed comprehensive project plans, including defining project scopes, budgets, and schedules. • Measured and analyzed data outcomes to support public health initiatives, and treatment of diseases. • Completed data analysis to assess, develop survey, and feasibility questionnaires. • Performed data collection and meticulously followed research protocols, operational guidelines, and case report form requirements.

• Performs all clinical monitoring/site management activities for assigned projects in accordance with Premier Research’s standard operating procedures • Acts as Premier Research’s direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol • Conducts qualification visits (QV), site initiation visits (SIV), Close out visits (COV), and monitoring visits (MV) at assigned clinical sites • Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines • Functions as a mentor and role model for other CRA team members

• Manages clinical monitoring activities, including: Arranging on-site visits and logistics, establishment of a site recruitment plan in collaboration with site staff during QV, monitoring completeness and quality of Regulatory Documentation, performing site documentation verification, data collection and drug accountability in accordance with ICH GCP guideline, monitoring patient safety on-site and addressing any violations in a timely manner • Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies • Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff. • Communicates common site trends to Lead CRA and other project team members • Ensures Serious Adverse Event (SAE) reporting according to project specifications • Responds to requests from investigative sites in a timely fashion

• Prepared for site monitoring by arranging on-site visits and logistics • Performed pre-visit site documentation verification • Conducted qualification visits, site initiation visits, interim monitoring and close-out visits at assigned clinical sites. • Responsible for the scheduling and conducting of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan. • Monitored completeness and accuracy of data collection to ensure study participant safety and data integrity. • Identified any protocol deviations or scientific misconduct at the site level. • Performed remote monitoring and risk-based monitoring.

Provided support to the Clinical Research Coordinator by assisting with screening of patients for study enrollment. • Assisted with patient follow-up visits. • Completed patient visit documentation in source clinic chart. • Entered data into the EDC and responded to queries in timely manner.