Managed and supported multiple global clinical trials while adhering to regulatory standards and meeting tight timelines. Played a lead role in the start-up, conduct, and close-out phases of multiple projects, ensuring seamless project transitions and client satisfaction. Developed a comprehensive understanding of delivery framework, contributing to the identification and mitigation of data quality issues and risks, thus maintaining high standards of clinical activities. Acted as the primary point of contact for study sponsors, effectively managing client relationships and proactively addressing risks. Maintained accurate project narratives for stakeholders, ensuring reporting on service delivery and progress, which facilitated effective communication and decision-making. Fully accountable for budget and project plan updates, conducting regular reviews and updates to ensure alignment with project goals and financial targets. Participated in site initiation visits and close out visits, conducted staff training, set-up external access to internal systems, provided ongoing site support, maintained stock supplies, and regularly communicated with researchers via email and meetings.  Monitored ongoing data collection, including writing plans and tools, site data verification and reconciliation, issuing and resolving queries by working with site staff. Worked closely with internal teams to ensure quality data collection from sites and progress towards related endpoints.  Supported development of internal SOPs and process improvements, and ensured consistency, quality, and compliance with global clinical standards, ICH / GCP guidelines, federal regulation requirements, sponsor protocol and timelines, and IRB policies. Lead and contributed to the development and review of study materials, including protocol schedule, ICFs, reference manuals, patient materials, presentations, source document completion guidelines, etc.

Demonstrate flexibility, reliability, and adherence to a self-directed schedule to interpret and follow established guidelines while providing feedback on text, web pages, images, and other types of information returned from internet search engine queries in terms of quality and relevance. Employ excellent communication, attention to detail, and strong organizational skills to prioritize and handle multiple activities in a timely manner, including job tasks, regular training, and assessments

Added value and supported organizational objectives by building studies into the clinical trial data management system, including protocol visits and budgets. Assisted in ensuring high-quality, high-volume, and efficient screening by using data collected by in-office coordinators to complete medicalhistory and run reports. Demonstrated proficient use of office equipment and technology to create high-impact spreadsheets, assisting the team in tracking visits, stipends, budgets, and other pertinent data.

Functioned as lead coordinator for industry-sponsored adult cardiology catheterization laboratory device studies and backup coordinator on electrophysiology and pharmaceutical studies. Applied knowledge and understanding of all site protocols, contracts, and budgets, resulting in selection to implement the site’s clinical trial data management system with continued maintenance, including new study development and staff training.

Oversaw smooth operation of Phase II-III clinical pharmaceutical trials, which included collecting data, informing participants about study objectives, and administering questionnaires. Assisted Research Director in department administrative duties, adhering to regulatory trial standards.

Planned day-to-day activities for monitoring of Phase II-IV clinical oncology pharmaceutical trials and investigator-initiated trials. Maintained a high level of attention to detail to ensure safety while processing blood and tissue and shipping specimens to central laboratories. Delivered quality, timely reports to both local and central IRBs.

Developed, implemented, and supported the research process by assisting investigators in study design, completion of the approval process, and management of data specific to Phase I-III clinical pharmaceutical trials. Prepared and submitted Institutional Review Board (IRB) paperwork in a timely manner and maintained all regulatory document submissions.