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Summary

Experienced Clinical Research Associate (CRA) with a Medical Doctor degree (MD) 18 year experience in clinical research, writing study protocols, conducting and monitoring clinical research / studies Personally recruited 350+ subjects for Medical Device study Co-wrote Protocols and designed Forms Successfully field-monitored (field visit) for protocol compliance and GCP-ICH, FDA and NIH and sponsor SOP compliance Coached site team on CFR and local regulations, with great results. Successfully trained and monitored site project team on standard forms (1572, CRF, eCRFs, AE/SAE, ICF, NTF) Managed pharmacy set up, storage, product accountability Expertise: subject protection & ICH-GCP Managed to deliver on-time, under pressure, improving communications between CRC, IRB, PI, CRO, Sponsor, as per study Protocol and CRO-SOP as in-house CRA Expert interpretation of clinic data, CRF source (raw) data verification Extreme (really) attention to detail Monitored multi-site teams for correctly creating and filing documents for Oncology, Onco-Dermatology and Surgical Device trials Expertise in creating, proofreading and improving Forms Expertise writing visit reports (as CRA) Administered ICF to 5,000+ subjects in the last 15 years Conducted risk based co-monitoring, field visits for site screening, pre study, routine, scheduled, self audit, close outs As CRA monitored AE/SAE were accurately and timely reported to IRB and sponsor Great results working with difficult cross cultural teams Excellent problem solving, innovation and win/win negotiations Successfully carried Medical Liaison (derma oncology, infectious disease, medical device) duties Successfully managed teams of up to 22 members on multi tasking duties Current ACRP and SoCRA Seeking: Clinical Research Associate or related position Expertise: Dermatology, Eye and Vision, Medical Device, Bionics, Oncology and Infectious Disease English, Spanish Travel 85%, immediate relocation

Experiences

Past Experience

  • Clinical Research Associate III
    January 2010 --- June 2015
    CRA monitor / manager of clinical studies with utmost respect for ICH / GCP / FDA / IRB / worked as principal contact pivot between PI-subPI and Sponsor, CRC and IRB-IEC / vigilant of SOP compliance / reviewing CLIA Certification, experience in proposed site screening, site setup, pre study visit reporting, trial team training, close-ups. Responsibly and timely reported AE-SAE / monitored that Blinding and Unblinding Procedures followed guidelines (protocol + regulations + SOP) / reviewed filing for IND / MedDev / tutored trial personnel on proper CRF routines / eDC / FDA and CFR Compliance/ Local Regulation Compliance (FCR-HHS) and test article-drug accountability / explained and guided PI to ethically and correctly fill Form 1572 / experienced in Enrollment, reviewed all versions of approved ICF (informed consent) and instructed - supervised ICF administration, as well as witnessing freely signed assents for pediatric/adolescent subjects. Explained and administered HIPAA forms. Protocol deviation detection NTF and timely reporting. Great rapport with PI, CRC and site team.

  • Senior Clinical Research Associate
    January 1998 --- December 2009
    Monitoring clinical research for ICH GCP guidelines, form exactness and timely reporting, file completeness, patient safety and privacy while managing a challenging staff. Experienced handling, managing, monitoring trials. Directly interacted with more than 5,000 subjects. Monitored as principal CRA, maintained team Quality standard (QC/QA/QM) Conducted clinical studies as subPI and coPI, published clinical trial papers of those studies, traveled around the world as scientific meetings as speaker. Trained team, recruited and administered ICF for thousands of subjects, both in English and Spanish. Monitoring in four locations simultaneously. Managing experience.

  • Clinical Research Intern, MD 1 year internship, ICU, Neurology, Infectious Disease, Cardiology
    January 1996 --- December 1996
    Monitored (in-house) clinical trials for nephrology, dermatology and ONCOLOGY. Tutored PI on correctly filing 1572. Checked design of CRF, ICF and other standard forms. Supervised the accountability for maintenance and security of trial drugs, all forms, filing correctly, interaction with IEC, overview correctness and completeness of MTF and CRFs. Trained associated personnel, recruited and instructed subjects, used inclusion / exclusion criteria, administered and filed ICFs. Monitored compliance to ICH GCP, CFR and local regulations. As a Medical Intern the duties performed included: Diagnosed and Treated hundreds of patients while rotating in Internal Medicine, Emergency / Trauma Room, Pediatrics. OBGYN, Surgery and Intensive Care Unit. Emphasis in Oncology in a busy teaching Hospital facility of 200+ beds. Assisted in positions as subInvestigator, IRB and CRA / monitor duties in multiple studies. Publishing credits on study. After full year graduated with 100/100 score after the 12 months in-house (live in) research medical doctor (paid internship) position.

Knowledge

LinkedIn Assessment :
CRAICH-GCPCRFBiotechnologyClinical researchPharmaceutical IndustryFDA GMPProtocolScientific AnalysisCRA-II / CRA-III / M.D.CTMSSOPRegulatory affairsRegulatory submissionsCROClinical trialsEDCFDAINDGCPClinical Data ManagementTherapeutic AreasClinical monitoringoncologyClinical DevelopmentIRBInfectious diseasesLife SciencesMedicineDrug DevelopmentCardiologyPharmacovigilanceHealthcareDermatologyNeurologyMedical DevicesResearchMedical writingQuality Assurance (QA)managementDiabetesHospitalsVaccinesInternal medicineMicrosoft OfficeImmunologyClinical operationsClinical Research Associates

Skills and Expertise

Self Assessment :
Develop protocols Develop clinical trial protocols Monitor a clinical study Search literature on clinical trialsCoach clinical staffCreate clinical documentsDesign clinical presentationDesign clinical trialDesign exclusion criteriaDesign inclusion criteriaConduct close-out visitsDevelop clinical strategyDevelop clinical trial protocolsEnsure good clinical practice (GCP)Indentify clinicians to conduct clinical trialsInteract with pre-clinical scientistsDevelop clinical hypothesesClinical data collectionMaintain clinical evaluation reportsManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage publication strategy of clinical trial resultsMonitor a clinical studyMonitor clinical trials Persuade clinicians to conduct clinical trialsPlanning clinical studiesPrepare CMC source documents related to clinical trial applicationPresent clinical resultsProvide medical content for clinical development planPublication of articlesReport study conclusionsReview clinical study reportsReview exclusion criteriaReview inclusion criteriaSearch literature on clinical trialsSet up a clinical studySupervise clinical monitorsTranslate clinical research concepts into specific objectiveswrite and maintain clinical evaluation reportsWrite clinical evaluation reports Assure medical qualityParticipate in medical reviewRead medical literatureCollaborate with medical teamMaintenance of biomedical equipmentReview medical reportsWrite medical reportsProvide medical insightslifesciencePublish scientific projectsExtrapolate dataDevelop regulatory strategyLabeling compliance with local regulationsPrepare regulatory documentsRegulatory submissionsRegulatory documentationWriting regulatory documents Interact with nurses Interact with physicians Guide students Design case record forms Build and manage the Trial Master File (TMF) Build the CMC development plan Interpret data Use a confocal microscopy Write papersAdminister supply requestApprove queriesResolves queriesReview queriesConduct monitor visitsFacilitate sponsor monitoring visitsInitiation visitSchedule sponsor monitoring visitsSchedule trial visitsScheduling trial visitsAttend investigator meetingCollaborate with principal investigator

Education

  • CME for BLS Basic Life Support CPR for the Health Care Provider in Advanced Cardio Pulmonary Resucitation from Baylor University in 2015
  • Patient Safety CME in Harvard Med School CME from Harvard University in 2006
  • Non Verbal Communications CME in MD Anderson Cancer Center from The University of Texas Health Science Center at Houston in 2004
  • Doctor of Medicine (M.D.) in Medicine, Surgery, Clinical Research from Universidad Autónoma de Guadalajara in 1997

Training and Certification

  • Biological - Chemical Weapons Certification
  • Challenging Cases in Toxicology Certification
  • Clinical Depression SJ'sW Certification
  • Clinical Neuroradiology Head/Neck Certification
  • Clinical Spectroscopy Certification
  • Endocrine Emergencies Certification
  • Human Research Participant Protection Certification
  • Member of ACRP Certification
  • Member of SoCRA Certification
  • Presentation of RedEye Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Native
Spanish
Native

Area / Region

New York, NY, United States

Others

Driving License
  • No