Rosemarie Abary, MD, MSN, RN

• Oversaw the preparation and execution of complex oncology trials, ensuring data integrity and patient safety. • Led the conduct of clinical trials from start-up to closeout in compliance with ICH-GCP standards. • Evaluated site capabilities and managed investigator recruitment to enhance trial efficiency.

On Assignment with Metsera for Worldwide Clinical Trials/ Actalent, LLC • Conducted rapid feasibility assessments across 28+ clinical trial sites within six weeks to enhance site selection. • Led pre-study, initiation, and interim monitoring visits, ensuring compliance with protocols and regulatory standards. • Mentored junior CRAs and site staff, delivering targeted training to improve protocol adherence and monitoring quality.

Built and sustained strong investigative site relationships to ensure consistent site performance and clear communication, advancing study objectives. Executed site evaluations, study initiations, monitoring visits, and close-outs strictly following Good Clinical Practice and regulatory standards. Collaborated with site teams to design and implement patient recruitment and retention plans, boosting enrollment success. Guided regulatory document collection and Institutional Review Board/Independent Ethics Committee approval processes, accelerating study start-up timelines. Identified site issues proactively, applying corrective and preventive measures to maintain study integrity and timelines. Trained and integrated new investigators into clinical trials, enhancing site capability and compliance. Acted as primary escalation contact, resolving site challenges through effective collaboration with internal and external stakeholders. Coordinated shipment and receipt of study materials such as Case Report Forms (CRFs) and manuals to study sites, maintaining logistical accuracy. Completed final close-out visits and reports, confirming study closure activities met regulatory and sponsor requirements. Assessed, monitored, and trained site personnel on strict protocol adherence to safeguard patient safety and data quality. Reviewed study subject safety information and informed consent documentation to ensure regulatory compliance and participant protection. Performed source document verification (SDV) to confirm compliance, data accuracy, and patient safety across sites. Reviewed CRFs, both paper and electronic data capture (EDC), assisting sites with data query resolution to maintain data integrity. Supported site maintenance of the Investigator Site File, ensuring regulatory documentation was complete and current.

• Built and sustained strong investigative site relationships to ensure consistent site performance and clear communication, advancing study objectives. • Executed site evaluations, study initiations, monitoring visits, and close-outs strictly following Good Clinical Practice and regulatory standards. • Collaborated with site teams to design and implement patient recruitment and retention plans, boosting enrollment success. • Trained and integrated new investigators into clinical trials, enhancing site capability and compliance. • Acted as primary escalation contact, resolving site challenges through effective collaboration with internal and external stakeholders. • Assessed, monitored, and trained site personnel on strict protocol adherence to safeguard patient safety and data quality. • Reviewed study subject safety information and informed consent documentation to ensure regulatory compliance and participant protection. • Performed source document verification (SDV) to confirm compliance, data accuracy, and patient safety across sites. • Reviewed CRFs, both paper and electronic data capture (EDC), assisting sites with data query resolution to maintain data integrity. • Supported site maintenance of the Investigator Site File, ensuring regulatory documentation was complete and current. • Reviewed clinical trial protocols for Phase Ib/2a Oncology trials, identifying methodological strengths and gaps. • Analyzed endpoints, inclusion/exclusion criteria, and study controls to ensure robust trial design. • Interpreted trial results and summarized safety and efficacy findings to inform study decisions. • Validated statistical analysis plans for completeness and accuracy, supporting data integrity. • Identified operational and scientific risks, contributing to proactive risk management in oncology clinical trials. • Completed final close-out visits and reports, confirming study closure activities met regulatory and sponsor requirements.

• Performed feasibility studies to assess potential clinical trial sites, reviewing and evaluating over 28 sites within 6 weeks to ensure strategic site selection for optimal study outcomes. • Conducted pre-study, initiation, and interim monitoring visits, rigorously adhering to protocol requirements to maintain compliance and data integrity. • Led global clinical research associate (CRA) activities, coordinating communication and monitoring efforts across multiple sites to streamline operations. • Mentored and guided less experienced CRAs and site personnel, fostering skill development and adherence to clinical trial standards. • Designed study-specific tools and templates, improving operational efficiency and standardizing monitoring processes. • Created and delivered training sessions for study team members and colleagues, enhancing protocol understanding and execution. • Collaborated with Project Management to evaluate study milestones and deliverables, ensuring alignment with timelines and quality standards. • Compiled and ensured completeness of regulatory and ethics submission documentation, including Institutional Review Board (IRB) and Independent Ethics Committee (IEC) approvals and informed consent materials. • Documented all monitoring activities and site visit findings through comprehensive written reports, supporting audit readiness and transparency with goal metrics of 1000/o. • Provided input into protocol and CRF design to enhance study feasibility and data collection accuracy. • Updated site-related documents for filing in the Trial Master File (TMF), ensuring regulatory compliance and documentation accuracy. • Ensured compliance with investigational product (IP) receipt, accountability, return, or destruction, safeguarding study drug integrity. • Conducted accompanied site visits to assess or train other CRAs, promoting quality and consistency in monitoring practices.

In my role at ICON plc, I was instrumental in managing oncology clinical trials, focusing on data accuracy and patient safety. I conducted site feasibility assessments and optimized clinical operations through effective site selection and initiation activities. My responsibilities included budget management and presenting progress updates to senior management, ensuring alignment with regulatory compliance and study objectives.

• Managed over 15 Phase II-IV study sites, ensuring 100% compliance with regulatory standards and study protocols. • Coordinated site initiation, monitoring visits, and close-out activities, successfully reducing study delays by 20%. • Collaborated with cross-functional teams to enhance operational efficiency and maintain high-quality standards in clinical research.

• Coordinated pre- and post-exposure prophylaxis HIV trials, managing patient recruitment of participants who met inclusion and exclusion criteria, and overseeing informed consent processes to ensure compliance and ethical standards. • Delivered targeted community presentations, fostering engagement and trust within diverse populations through effective communication.