Study Lead for Phase I/II/III HIV and Ebola studies with global experience including North America, EMEA, and Africa.

CRO Vendor Manager within a Global environment for Event-driven Phase III PAH trials in Latin America.Career highlights include International Accompanied Site Visits, EMA/FDA Inspections, Trial Master File Management, Database Lock, and Start-up/End of Study execution for pivotal Phase III PAH study Seraphin (FDA and EMEA approved Opsumit).

Worked in Phase III/IV development as an in-house/on-site clinical trial monitor. I manage and maintain all regulatory documents associated with clinical research, IRB submissions, and budget/contract negotiations as well as review of grant payments made to investigator sites. I also have experience in project close outs and database lockdown.• Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites.• Monitor (pre-study, initiation, routine, and close-out) investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines.• Write visit reports, confirmation and follow-up letters• Assist in developing Source Documents and Case Report Forms (CRF) for clinical trials• Review and verify CRFs and other clinical data for completeness and accuracy.• Generate and resolve queries with site personnel• Create and maintain tracking spreadsheets and monitoring tools.

At Memorial Hospital, I worked within a team environment to provide the best patient care possible within the hospital regarding pharmacy operations. I have gained considerable knowledge in the distributive frequencies, strengths, interactions, compatibilities, and adverse reactions of medication used within the hospital along with medical terminology used among my peers including pharmacists, nurses, doctors, and other technicians.

At RadPharm, I worked under eleven different protocols, all within either Phase II or Phase III of their clinical trial in accordance with GCP/ICH guidelines and under the requirements specific to each protocol. I managed and maintained all images and data submitted from clinical research sites located around the world, while maintaining communication with sponsor representatives and research personnel from each site.• Worked within a team to execute technical and clinical functions specific to each study protocol and according to RadPharm’s standard operating procedures.• Entered, maintained, and tracked data into several computer databases.• Prepared Media, including CDs, ODs, Media Cards, X-Ray Film (Originals, 2nd Originals, and Copy) for Quality Assurance and assisted in preparation of source documents for reading of exams by Radiologists and Oncologists.