Morgantown, Pennsylvania, United States
Clinical research professional with pharmaceutical experience in Phase II-IV clinical trials involving various therapeutic areas such as Nephrology, Gastroenterology, Musculoskeletal Pain, Urology and Oncology. Demonstrated expertise in study start-up, site management and vendor management. Record of mastering new technologies quickly and is able to provide training and mentoring.
Responsible for clinical study operations from study start-up through close-out (e.g. vendor management, study timeline tracking, inspection readiness, etc) Therapeutic Area Experience: Phase III (Oncology - gastric)
Supported Clinical Trial Manager with study start-up and ongoing site/vendor management activities o Therapeutic Area Experience: Phase III (Nephrology) - Worked on two global Phase III registrational trials which resulted in a successful NDA submission o Therapeutic Area Experience: Phase II (Oncology - melanoma) - Assisted with vendor management activities for IVRS, central IRB, home healthcare, central lab and the site facing investigator portal
Supported the change request process and primary support team for Pfizer Clinical Trial Management System (CTMS) and PfizerTrials Portal (web-based investigator portal)
Participated in the establishment of a new centralized team focused on providing clinical study teams with full support of CTMS (IMPACT) o Assisted in the development and implementation of new business processes o Contributed to ongoing process improvements and data cleanup activities o Established an offshore team in India as part of process improvements
Supported Clinical Trial Manager (CTM) with study start-up and ongoing site management activities o Acted as primary contact for incoming/outgoing site communications related to study conduct o Supported the startup and ongoing management of ePRO vendor o Therapeutic Area Experience: Phase III – Pediatric GERD
Sr. Regulatory Coordinator, August 2005 – March 2006 o Supported the Director of Regulatory with development of detailed organization and filing guidelines for the Trial Master File (TMF) o Created a database to be used by regulatory coordinators and site monitors to track documentation issues to resolution Clinical Project Assistant, March 2004 – July 2005 o Served as a liaison between investigators, the sponsor and internal functions to track study progress against planned milestones o Assisted the Medical Monitor with the collection, reporting and tracking of various safety data (e.g., Serious Adverse Events (SAEs), abnormal labs, data queries, etc) o Therapeutic Area Experience: Phase IV - Musculoskeletal Pain & Urology