•Supervise and manage site management & monitor trial-team members' adherence to sponsor-specific administrative policies with guidance. Encourage team members to attend appropriate training and meetings. Support the department's mission, goals, and organizational activities.•Manage the development, coordination, and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems, and daily supervision of the clinical operations team.•Reduce site non-compliance by 25% through proactive site engagement and training, improving overall data quality and protocol adherence during clinical trials.•Enhance study startup timelines by 25% by streamlining site selection processes and regulatory document submission, improving overall study efficiency.•Ensure monitoring visits are scheduled and performed per the Clinical Monitoring Plan and according to the performance of the clinical site and the project team's needs.•Participate in developing the Protocol, Clinical Monitoring Plan (CMP) protocol revisions and amendments, scope of work, and operations manual with guidance from internal and external stakeholders.•Lead the development, coordination, and implementation of monitoring and administrative strategies essential to the successful management of clinical trials research conducted by principal investigator(s) at Duke University School of Medicine.•Participated in site selection and training site personnel regarding the trial; oversaw site monitoring of the trial and follow etc., ensure identified deficiencies are corrected; travel as needed inside and outside of the USA to accomplish responsibilities.•Conducted monitoring visits to the integrity of clinical data concerning accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.

•Managed multi-site trials across five therapeutic areas, delivering timely updates and resolving protocol deviations, contributing to accelerated study timelines by 20%.•Played a critical role in the successful launch of a COVID-19 vaccine trial, ensuring compliance with international regulations and contributing to the study’s expedited approval process.•Successfully monitored trials across more than 50 sites globally, maintaining compliance with diverse regulatory environments and contributing to the global success of clinical programs.•Provided timely responses to site management and monitoring questions from external and internal stakeholders, including regulatory authorities/ethics committees.•Resolved over 100 protocol deviations in collaboration with site teams, ensuring continuous protocol adherence and reducing the risk of regulatory penalties.•Drove the successful management of critical studies within Ophthalmology, Dermatology, and Infectious Disease contributing to groundbreaking research in areas such as COVID-19 vaccines and the use of EYLEA(Aflibercept) to treat patients diagnosed with WET AMD.

•Successfully led over 300 site initiation visits (SIVs), ensuring all assigned staff were fully trained and compliant with GCP, ICH, and trial-specific protocols.•Executed over 500 Interim Monitoring Visits (IMVs), maintaining a high level of protocol compliance and ensuring the integrity of study data across multiple therapeutic areas•Drove the successful management of critical studies within Oncology and CNS, contributing to groundbreaking research in areas such as Parkinson’s Disease, and Breast Cancer.•Achieved a 100% success rate in passing sponsor and FDA audits, with no major findings related to study data quality or protocol compliance.•Trained over 100 site staff on GCP, ICH guidelines, and study-specific protocols, leading to improved site performance and reduced protocol deviations.•Completed more than 150 Close-Out Visits (COVs), ensuring thorough reconciliation of investigational products and regulatory documents, leading to successful study closures with no major audit findings.

•Successfully led over 100 site selection visits (SSVs), ensuring all assigned staff were fully trained and compliant with GCP, ICH, and trial-specific protocols.•Prepared and meticulously submitted site monitoring reports, confirmation/follow-up letters, and assorted documentation, strictly adhering to client Standard Operating Procedures (SOPs).•Served as the primary point of contact for investigators and site staff, maintaining regular contact with study sites to ensure GCP/ICH/Protocol compliance, and assessment of accrual rate.•Monitored case report forms and electronic data following protocol, and applicable domestic and international regulations. •Proficiently handled Serious Adverse Event (SAE) reconciliation and data integrity assessments, mitigating regulatory risks and maintaining compliance with FDA and EU standards.•Assessed Drug accountability, dispensation, and compliance at the investigative sites.