Francis E. Email & Phone Number

Durham, North Carolina, United States

• 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.
• 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.
• 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.

United States

• 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).

United States

• 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.

Master'S Degree, Business Administration And Management, General, 4.0

Bachelor'S Degree, Business Administration, Management And Information Systems, 3.5