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Click here or scroll down to respond to this candidateCandidate's Name , LLCLori A. BarbericSenior Clinical Research ConsultantAvon, Ohio Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLEPROFESSIONAL SUMMARYA certified clinical research associate, and over 22 years of experience in clinical research and the pharmaceutical industry. Has monitored for both clinical research organizations and pharmaceutical companies. Obtained a Bachelors Degree in Healthcare Administration in May 2001. Established Candidate's Name , LLC in May 2009 and has specialized in working for short-term/long-term contracts as CRA, CMA and Patient Recruitment Specialist. An adaptable and result oriented professional who was acknowledged and awarded by the Global Directory of Whos Who in June 2022.EMPLOYMENT HISTORYEmployer/From ToRoles & ResponsibilitiesCandidate's Name , LLC1/2024 to presentContract Clinical Research AssociateConducted routine monitoring visits to assess protocol, regulatory, and ICH compliance.Ensured the subject enrollment, ICF process, reviewed EDC against source data such as patient diaries, laborPPD/Thermo-Fisher Scientific11/2022 to 1/2024Contract Clinical Research AssociateConducted routine monitoring visits to assess protocol, regulatory, and ICH compliance.Ensured the subject enrollment, ICF process, reviewed EDC against source data such as patient diaries, laboratory results, etc.Ensured all the essential documents are maintained in the investigator site folder and is updated with new or amended documents.Assured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs).Black Diamond Network (Scipher Medicine, AIMS in RA)12/2021 to 6/2022Contract Clinical Research AssociateConducted remote monitoring of clinical data, and performed clinical data entry.Ensured the subject enrollment, ICF process, reviewed EDC against source data such as patient diaries, laboratory results, etc.Candidate's Name , LLC(The Cleveland Clinic Foundation)11/2016 to 3/20/2020 (due to Covid)Contract Clinical Research AssociateConducted routine monitoring visits to assess protocol, regulatory, and ICH compliance.Ensured the subject enrollment, ICF process, reviewed EDC against source data such as patient diaries, laboratory results, etc.Ensured all the essential documents are maintained in the investigator site folder and is updated with new or amended documents.Assured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs).Acerta Pharma(Advanced Clinical)Columbus, OH6/2014 to 6/2016Contract Clinical Research Associate Co-MonitoringPerformed clinical co-monitoring in compliance with FDA regulations and all related SOPs.Ensured all the essential documents are maintained in the investigator site folder and is updated with new or amended documents.Assured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs).Co-Monitored for interim visits.Ensured the subject enrollment, ICF process, reviewed EDC against source data such as patient diaries, laboratory results, etc.Coordinated collection of information from investigational sites.Parexel International(Clinical Resource Network)Cleveland, OH1/2012 to 6/2013Contract Clinical Monitoring AssociateManaged 45 sites in order to set-up, monitor, and close-out.Coordinated collection of information, regulatory documents from sites.Organized recruitment strategies, monitoring visits, and delivery of study supplies to all sites.Managed daily operations of each site.I3 ResearchCleveland, OH11/2006 to 12/2010Contract Clinical Research AssociatePerformed clinical monitoring in compliance with FDA regulations and all related SOPsMonitored for study initiation, dose escalation, interim and close out visitsCoordinated collection of information from investigational sitesCompleted trip reports, reviews trips reports, and is responsible for all communication with sitesMentored and trained CRAsQuintiles, IncCleveland, OH1/2006 to 6/2006Contract Clinical Research AssociatePerformed clinical monitoring in compliance with FDA regulations and all related SOPsMonitored for study initiation, dose escalation, interim and close out visitsCoordinated collection of information from investigational sitesCompleted trip reports, reviews trip reports, and is responsible for all communication with sitesManaged clinical databaseHealthcare CommunicationsGroup, CACleveland, OH assignments6/2005 to 10/2005Patient Recruitment SpecialistImplemented recruitment strategies for designated clients. Tailored scientific investigational drug support information to meet the needs of the local medical/patient communityDisseminated scientific information, knowledge and services in a timely, ethical and patient focused mannerActed as a liaison for clinical trials to the medical community and research participantsDesigned and performed presentations and implement marketing strategies of investigational drug for the medical community and patientsScreened, collected and tracked information on patient recruitment vendors.Managed patient recruitment vendors in support of clinical trial enrollmentEducated sites on patient recruitment/retentionOmnicare10/2004 to 6/2005Contract Clinical Research AssociatePerformed clinical monitoring in compliance with FDA regulations and all related SOPsMonitored for study initiation, dose escalation, interim and close out visitsCoordinated collection of information from investigational sitesCompleted trip reports, reviews trip reports, and is responsible for all communication with sitesQuintiles, IncCleveland, OH5/2004 to 11/2004Contract Clinical Research AssociatePerform clinical monitoring in compliance with FDA regulations and all related SOPsMonitoring visits include evaluation, initiation, interim and close out visitsCoordinates collection of information from investigational sitesCompletes trip reports, reviews trip reports, and is responsible for all communication with sitesQuintiles, Inc.Cleveland, OH3/2003 to 3/2004Clinical Research Associate/Clinical Team LeaderPerformed clinical monitoring in compliance with FDA regulations and all related SOPsM Monitored for study initiation, dose escalation, interim and close out visitsCoordinated collection of information from investigational sitesCompleted trip reports, reviewed trip reports, and responsible for all communication with sitesIMARC Research, Inc.Columbia Station, OH3/2001 to 3/2003Clinical Research Associate/AE WriterMonitored many cardiovascular device/drug studies including PVD, coronary stent, iliac stent and endovascular graftsWorked with sponsoring companies, contract research organizations, and investigators to assist in the drug and device research processProcessed/Edited AE reports to CEC on a monthly basisTHERAPEUTIC INDICATIONS/PROJECT EXPERIENCEProject ExperienceProject descriptionDescription of Responsibilities/TasksIncluding start and end datesPhaseIndication&Drug classIIIbType II Diabetes2006-2007 Full Monitoring Responsibilities2006-2007 Site Management Responsibilities2022-2023 Full Monitoring ResponsibilitiesII/IVNeurology/Psychiatry2004 Full Monitoring Responsibilities (Bipolar)2005 Recruited subjects to meet timelines for Psychiatry study (Bipolar and Schizophrenia)2012 Co-monitored (Depression and Anxiety)II, IIIWomens Health2004-2006 Full Monitoring ResponsibilitiesIIICOPD2003 Full Monitoring Responsibilities2022-2023 Full Monitoring ResponsibilitiesDeviceUlcerative Colitis2002-2003 Full Monitoring Responsibilities and some Clinical Team Lead ResponsibilitiesIIIAsthma2002-2003 Full Monitoring ResponsibilitiesDeviceVascular Surgery (In-Patient) Study2001-2003 Full Monitoring ResponsibilitiesDeviceCardiology/Stent Study2001-2003 Full Monitoring Responsibilities20162020 Full Monitoring Responsibilities2022-2023 Full Monitoring ResponsibilitiesI, IVObstetrics/Gynecology2001-2003 Full Monitoring ResponsibilitiesII, III, IVCardiology/HTN and Inpatient Genetic Study2004 2005 Full Monitoring Responsibilities2009 2010 Full Monitoring ResponsibilitiesI, IIIOncology2003-2004 (Breast Cancer/Sarcoma)2008-2009 (Ovarian) Full Monitoring Responsibilities2011-2012 (Myelodysplastic Disease) Full Monitoring Responsibilities2014 2016 Chronic Lymphoid LeukemiaDeviceOphthalmology (Glaucoma)2004-2005 Full Monitoring ResponsibilitiesI, IIIPsoriasis/Rheumatoid Arthritis2004-2005 Full Monitoring Responsibilities2021-2022 Remote Data Entry and Monitoring of clinical dataINeurology/ADHD2008-2009 (Pediatric) Full Monitoring ResponsibilitiesIINeurology/Type II Diabetes2012-2013 Full Monitoring ResponsibilitiesIIInfectious Diseases (STD)2003-2004 Performed two Site Initiation Visits, Completed six SWAT visitsIIAutoimmune Disorder/Rheumatoid Arthritis2021-2022 Performed data entry and remote monitoring responsibilities.EDUCATION1998-2001Kennedy Western UniversityBachelors of Science Healthcare Administratration1999Youngstown College of MassotherapyCertified Massage TherapistCERTIFICATIONSApril 2011FDA RegulationsMay 2018CRA MentoringMay 2018Clinical TrialsAugust 2019Good Clinical PracticesSKILLS/SYSTEMS EXPERIENCEPC SKILLSMS WordExcelPowerpointOne NoteELECTRONIC DATA CAPTUREClincaptureInformMedidataRave |
