Experience

Clinlogix, Now Part of NAMSA

• United States
• Medical Device
• 1 - 100 Employee

• Senior CRA

  • Dec 2008 - Present

  Obtain Regulatory Documents, Perform SIV, IMV, and Close-Out Visits drug accountability,make sure site follow ICH, GCP, and FDA rules and regulations, check source documents against eCRF's, 100% source document verification, write Trip Visit Report, Expense Reports, train sites to protocol. Obtain Regulatory Documents, Perform SIV, IMV, and Close-Out Visits drug accountability,make sure site follow ICH, GCP, and FDA rules and regulations, check source documents against eCRF's, 100% source document verification, write Trip Visit Report, Expense Reports, train sites to protocol.



Implemetrics, Inc.

• Government Administration
• 1 - 100 Employee

• Senior CRA

  • Oct 2007 - Nov 2008

  Field Monitoring, Swat Team, Co-monitoring, obtaining and reviewing Regulatory Documents, Source Data Verification for EDC trials and paper trials, Monitored Device Studies(Diabetes), captured A/E's and SAE, Drug Accountability(monitored and returned). Followed GCP's, FDA Rules and Regulation, ICH Guidelines, Performed SIV, IMV, and Close-out Visits. Field Monitoring, Swat Team, Co-monitoring, obtaining and reviewing Regulatory Documents, Source Data Verification for EDC trials and paper trials, Monitored Device Studies(Diabetes), captured A/E's and SAE, Drug Accountability(monitored and returned). Followed GCP's, FDA Rules and Regulation, ICH Guidelines, Performed SIV, IMV, and Close-out Visits.



The Marsalis Group

• Senior CRA

  • Jul 2004 - Oct 2007



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regional Clinical Research Associate

  • Nov 2003 - Nov 2004

  Responsibilities included study start-up, planning of site recruitment list of new Principle investigators, QA visits, SWAT Team visits, SIV, and Routine Monitoring visitsHelped plan regional team meetings, and presented current advances in the field of monitoringManaged and Monitored assigned sites, drug accountability, inputted information for electronic data capture for CRFs and Regulatory documentsPerformed close-out visits per protocol FDA and ICH guidelinesVerified data queries



Icon Clinical Research, Inc

• Clinical Research Associate

  • Oct 2002 - May 2003

  Responsibilities include site selection Responsibilities include site selection



Celeris Corporation

• Clinical Research Associate

  • Jan 2000 - Oct 2002

  Conducted Pre-study visitsPrinciple Investigator selection, verify data queriesReview study files for completenessDrug accountabilityPrepare/Review regulatory documentsMonitor regulatory binders: 1572, CVs, and medical licenseWrote trip reports for appropriate visitsExpense report writingEnsure investigator is in compliance of protocol Conducted Pre-study visitsPrinciple Investigator selection, verify data queriesReview study files for completenessDrug accountabilityPrepare/Review regulatory documentsMonitor regulatory binders: 1572, CVs, and medical licenseWrote trip reports for appropriate visitsExpense report writingEnsure investigator is in compliance of protocol



Innovex/GlaxoSmithKline

• Clinical Nurse Educator

  • Jan 1999 - Jan 2000

  Responsible for implementing new respiratory CE program for primary care, pediatrics, pulmonary, internal medicine physicians, nurse practitioners, physician assistants, pharmacist, and registered nursesPerformed weekly informational presentations on new research medications, teaching devices, and NIH Guidelines, and new studies being doneProvided information on competitor's drugConducted health fairs for office staff, pharmacies, and doctorsTeam leader, devised business plans for territory and gave presentation to regional sales team



Racine Correctional Institution

• Nurse Clinician II/Study Coordinator

  • Dec 1998 - Dec 1999

  Responsibilities ensuring compliance with protocol accuracy of source documents and CRFsRecruited, screened patients and conducted study visitsMaintained regulatory binders and consented patients to participate in clinical trailsDevised protocols for Asthma, Diabetes, Cancer, Cardiac, Hypertension, and Infectious disease patients Started Hepatitis C monitoring of new drug Performed in-service training to staff and nursing students on new or revised proceduresAssisting physician with surgical procedures, dressing changes, immunization, blood draws, giving blood products, applying cardiac monitors, pacemaker checks/monitoringAdministered medicationsCharge Nurse



St. Frances Hospital

• Registered Nurse

  • Dec 1997 - Dec 1998

  Responsibilities included providing support to terminally ill patients, directed pastoral care, and facilitated problem solving between health services and families regarding delivery of careAdministered IV medications and cancer treatments, chemotherapy and radiation therapy, iodine therapy blood clotting products, anti-emetics, antibiotics, and red-blood cell booster products, immunization, applied monitoring devices, dressing changes: prepare patients for treatment and other test and/or proceduresPerformed palliative care, maintained central lines, and peripheral lines, coordinated services with other healthcare professionals, and families, charting, vital signsRadioactive Iodine treatment monitored, and treated patient during chemotherapy, BMT, radiation therapy in all disease stagesCharge Nurse, telephone triage, giving intubations of patients, administering TPN