A Taylor Email & Phone Number

• Oversaw the execution of clinical monitoring and site management activities, including site selection, initiation visits, routine monitoring, and close-out visits, ensuring adherence to protocols and regulations.• Conducted regular sign-off visits and performance assessment visits for CRAs, evaluating their competencies and providing feedback to improve performance.• Monitored study progress through regular review of CTMS, CRF, drug management, safety data, and data visualization dashboards, proactively identifying and addressing potential issues.• Led and mentored a high-performing team of 5 CRAs and CTAs, providing ongoing training, performance feedback, and career development guidance, resulting in improved team morale and productivity.• Developed and implemented comprehensive clinical management plans and site management plans for numerous clinical studies, outlining clear roles and responsibilities, timelines, and quality standards.• Collaborated with the regulatory team to ensure timely submissions and approvals to competent authorities and IRB/Ethics committees.• Supported the legal department in site budget and contract negotiations, ensuring fair and favorable terms for the company.• Developed clinical monitoring strategies that optimized study timelines and ensured high-quality deliverables.• Generated and utilized metric reports to track study progress, identify trends, and communicate potential issues to the project manager and CRAs

• Analyzed intricate data and made informed business decisions with guidance from management.• Strived to ensure all clinical deliverables aligned with the client’s expectations in terms of time, quality, and cost.• Preserved profitability by managing the clinical team efficiently and ensuring activities were within the scope of the contract.• Took on projects of moderate to high complexity independently and assumed the role of regional lead or Clinical Study Manager.• Achieved 100% compliance with quality and regulatory standards within the clinical monitoring team and investigational sites through stringent management and supervision.• Contributed vital information at monthly projection meetings, leading to a 10% decrease in project shortfalls.

United States

• Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalated quality issues to clinical project manager, clinical research specialist and/or line manager.

United States

• Established and maintains regular contact with investigators, vendors and study sites to ensure ICH-GCP protocol compliance, and assessment of accrual rates.• Ensured site compliance with study protocols, ICH-GCP, applicable regulations prior, during and following visits. Works with site personnel and study team to prevent, address and resolve issues.• Ensured the integrity of the data submitted on CRFs or other data collection tools by careful source document review.• Acted as a liaison between site personnel and the sponsor.• Performed monitoring visits.• Ensured compliance with protocols, regulatory requirements, and good clinical practices.

United States

• Collaborated with Study Management Team to drive successful execution of global clinical studies in rare diseases.• Documented monitoring activities in monitoring reports and follow-up letters.• Assisted in protocol feasibility analysis, contract assessment, site identification, and patient recruitment and planning.• Assisted in the creation of study materials (CRFS, operation manuals, protocols, etc.). • Assisted in the creation of departmental operating procedures and tracking systems.