Lorelei Pratt

Background

About Lorelei Pratt

Managed government and industry-sponsored drug, device and outcomes-based clinical trials from pre-trial assessments through study close-outs. Conducted budget negotiations. Oversaw the clinical trial agreement and hospital services agreement processes. Coordinated site initiations, subject recruitment, enrollment and follow-up. • Wrote site-specific informed consents and study documents. Assisted in development of protocol for an investigator-initiated, multi-site, prospective randomized trial. • Developed a tablet application/web-based data management system in conjunction with a star-up clinical data management company to collect and analyze data for use in upcoming investigator-initiated study. • Prepared and conducted study trainings for co-investigators and study staff. • Conducted studies in compliance with FDA and HIPAA regulations according to ICH and GCP guidelines. Reported adverse events, unexpected adverse events and serious adverse events according to IRB, HSPP, sponsor and regulatory requirements. • Oversaw and documented the informed consent process. Administered study questionnaires and conducted patient interviews. • Prepared IRB initial and annual submissions as well as amendments for local and central IRBs. Created study progress reports. • Ensured study protocols were followed precisely. Maintained the accuracy and integrity of subject data. Supervised data entry into electronic data capture databases. • Maintained current records of study personnel credentials and training. • Provided fiscal oversight for all clinical trials. Oversaw study invoicing and financial reporting.