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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Dovecote DriveQuakertown, PA Street Address
PHONE NUMBER AVAILABLE (c)EMAIL AVAILABLESENIOR SITE MONITORHighly efficient Senior Site Monitor with career expertise in monitoring clinical research for 20+ sites. Adept in proper subject consenting; source data verification and source data review including rectification and reporting of AE/SAEs. Collaborative professional skilled in accommodating high enrollers for multiple complicated oncology protocols. FDA Audit resulted in zero findings (i.e., no minor, major, or critical findings and or 483) for site conducting complex Phase I study. AREAS OF EXPERTISEClinical Research AE/SAE Reporting Site Management Sourcing (both Verification and Regulatory Compliance Internal and External Audit IP Accountability Staff Training PROFESSIONAL EXPERIENCEUniversity of Pennsylvania Thoracic SurgeryResearch Coordinator January 2023- 05MAY23Assisted lead research coordinator in surgical study for lung cancer for most aspects of clinical research, including but not limited to source data verification and/or rectification; AE/SAE reporting, rectification and completion; regulatory compliance; confirmation of requisite staff training completion; completion of data base locks within targeted timelines; and maintaining that site is in overall compliance and audit-ready at all times.Bristol-Myers Squibb October 2015-August 2022Senior Site MonitorManaged all clinical research monitoring activities for 20 sites, including, but not limited to: proper subject consenting; source data verification and/or rectification; AE/SAE reporting, rectification and completion; regulatory compliance; investigational product accountability; confirmation of requisite staff training completion; completion of data base locks within targeted timelines; and maintaining that all sites are in overall compliance and audit-ready at all times. Oversaw 22 sites in various stages of clinical research activity, from startup to closeout, including accommodating high enrollers for multiple complicated oncology protocols. Assisted with onboarding newly hired monitors, helping to instruct monitors in BMS monitoring particulars and specifics. Served as study monitor liaison (a monitor assigned to specific oncology study to liaise between central team and monitors in the field). Supported clinical supply operations internal team with monitoring input during internal meetings. Served as subject matter expert for monitors for in-house regulatory portal system. Novartis April 2015-October 2015Senior Clinical Research AssociateManaged all clinical research monitoring activities for 23 sites, including, but not limited to: proper subject consenting; source data verification and/or rectification; AE/SAE reporting, rectification and completion; regulatory compliance; investigational product accountability; confirmation of requisite staff training completion; completion of data base locks within targeted timelines; and maintaining that all sites are in overall compliance and audit-ready at all times. Oversaw 23 sites in various stages of clinical research activity, from startup to closeout, including accommodating high enrollers for multiple complicated oncology protocols. GlaxoSmithKline April 2010-April 2015Clinical Research AssociateCompleted 8 data locks over last approximately 15 months, all successfully within timelines and with no outstanding queries or missing data for sites under personal purview. Candidate's Name Page TwoReceived numerous incentive awards for work from both fellow monitors and central team members in recognition of work completed timely and with first-rate quality. Two studies are currently in submission to FDA, one study failed to reach statistically significant endpoint and five others were interim data analyses in continuing studies. Managed approximately 15 sites in various stages of clinical research activity, from startup to closeout, including accommodating high enrollers for five hematology protocols. Senior Study Manager, July 2005-April 2010Managed a number of global oncology studies from startup to closeout, including participating with in- house team during an FDA inspection for one of my lung cancer studies. FDA inspection for lung cancer was successful, as indication was approved after conclusion of the audit. Guided a GSK oncology study for VEGF inhibitor treating soft-tissue sarcoma as study manager for US and two INTL regions, from startup to database lock. Both US and INTL countries over- enrolled their targeted subject allocations despite poor feasibility results. Globally the study concluded ten months ahead of original timelines, and FDA and EMEA approval for the studys indication was achieved. Received internal Gold Award, one of highest GSK awards for successful management of VEGF study. Managed a PONV study for supportive oncology care and guided it from all phases of study startup through last subject, last visit. The study completed enrollment four months early and was used as part of an FDA submission packet for CINV. Managed a GSK oncology supportive care study as study manager in soft-tissue sarcoma indication through two amendments, while ensuring enrollment timelines remained on track. All original timelines were preserved, and enrolment was on track before study was placed with another monitor due to resourcing needs.ADDITIONAL RELEVANT EXPERIENCEPharmaNet, LLC, Sr. CRA, Study ManagerAdvanced Biologics, LLC, CRA, Quality Assurance Associate, Assistant Study Manager EDUCATIONBachelor of Science (BS), PsychologyBachelor of Science (BS), BiologySyracuse University |
