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Summary

 

Clinical Research Therapeutic Area:               CNS

                                                                         Endocrinology and Metabolic Syndrome                              

                                                                         Immunology

                                                                         Dermatology

                                                                         Oncology

                                                                          Hematology

                                                                          Cardiology

                                                                          Biomarkers

 

Professional Skills                                             Conduct Clinical trials Phase II to Phase IV, Study Feasibility, Identify                    

                                                                           Investigators sites,Initiation, Monitoring, Close out visit, Follow-up DCFs and      

                                                                           ensure correct archiving of files. Monitoring of pharmacy. Help and Follow -up   

                                                                           tthe regulatory submission. Site Management, Tracking Patient in data base

                                                                           Maintain all files and documents pertaining to Study, adverse events management                                                                            Management and Contact with external CRA

                                                                           Follow-up of Data Management Results. Bibliographic Search.

 

 

Experience in Informatics                               Word/ Excel/Power Point/Outlook

                                                                         Data Capture Trial: Share Point, In Form, Landa plus,    

                                                                         Tentelemed, IVRS, Sky web, Synclin, CTMS and other electronic data base.          

 

Languages                                                        English (verbal and written: fluent)

                                                                         French (verbal and written: bilingual)

                                                                          Spanish (verbal and written: mother tongue)

                                                                          Portuguese (verbal and written: fluent)

 

Clinical Study Experience

Over 10 years of experience working in clinical research with over 5 years of experience as Senior CRA

 

Experiences

Current Experience

  • Un-Blinded Senior Clinical Research Associate (CRA) Paris, France
    Since December 2015

    • Identifiy and Recruitment of investigators
    • Pre-study and initiation visits
    • Independent and proactive coordination of all the necessary acivities required to set up and monitor a study, including : Vendors management
    • Help in preparation of regulatory submissions
    • Design of patient informaion sheets and consent forms
    • Coordinate documents translation, verification and back translations where required.
    • Ensure timely submission of protocol/ consent/ Safety reports documents for ethics/ IRB approval
    • Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/ Sponsor site monitoring SOP/ WP
    • Ensure timely submission of protocol/ consent/ Safety reports documents for ethics/ RIB approval
    • Pre-study and initiation visits
    • Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/ SPonsor site monitoring SOP/WP, as appropriate
    • Maintain all files and documentation pertaining to studies
    • Motivate investigators in order to achieve recruitment targets
    • Complete accurate study status reports
    • Ensure the correct storage of drugs and the diligent account of all drugs in accordance withs SOPs.
    • Keep the project manager regulary informed.
    • Proces case record fo and sponsor confidentiality.
    • Maintain patient-out of investigator sites.
    • Ensure correct archiving of files on completion of a study.
    • Maintaint patient and sponsor confidentiality.

     

Past Experience

  • Senior Clinical Research Associate (CRA) Boulogne-Billancourt, France
    May 2010 --- August 2012

     

    • Out- sourcing Senior CRA at The Stallergene Laboratory.
    • Senior CRO at office.
    • Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
    • Conduct study feasibility activities.
    • Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
    • Assist with investigator meeting activities including organization, preparation and attendance
    • Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
    • Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
    • Establish and maintain good rapport with study sites.
    • Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines
    • Coordinate timely shipment of clinical supplies and study drug to sites.
    • Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
    • Maintain adequate site tracking records
    • Follow up of drug safety issues and safety reports in timely manner, if applicable
    • Communicate site study issues, concerns, and progress Project Manager, Clinical Team Lead and Clinical Research Manager accordingly
    • Assist with data query form (incl. query process)
    • Develop and implementation of corrective actions when appropriate
    • Prepare /review all patients tracking records
    • Input and maintain study information concerning subject status of financial reimbursement to sites.
    • Conduct and assist with administrative activities as a member of the project team.

  • Clinical Research Associate (CRA) Maisons-Laffitte, France
    September 2005 --- April 2010

    • Conduct study feasibility.
    • Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
    • Assist with investigator meeting activities including organization, preparation and attendance
    • Conduct regular monitorig visits in accordance with the CRO and Sponsor SOPs as apropiate.
    • Establish and maintain good rapport with study sites.
    • Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines
    • Coordinate timely shipment of clinical supplies and study drug to sites.
    • Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
    • Maintain adequate site tracking records
    • Follow up of drug safety issues and safety reports in timely manner, if applicable
    • Help when requested, in preparation of regulatory submissions
    • Assist with data query form (incl. query process)
    • Develop and implementation of corrective actions when appropriate
    • Motivate investigator in order to achieve recruitment targets.
    • Prepare /review all patients tracking records
    • Input and maintain study information concerning subject status of financial reimbursement to sites.
    • Conduct and assist with administrative activities as a member of the project team.

Personality

Self Assessment :
AdaptabilityAttention to detailCollaborationResiliency

Knowledge

BrightOwl Assessment :
Phases of clinical development (phase I to IV)
Self Assessment :
Acromegaly Phase II (3 centres) DiabetesCardiologyDermatologyEndocrinology and metabolismoncologyPhase IIPhase IIIPhase IVPulmonary diseasesMedical DevicesImmunologyHematologyCardiovascular diseases

Skills and Expertise

BrightOwl Assessment :
Monitor a clinical study Monitor a clinical study Monitor a clinical study Monitor a clinical studyCollaborate with project teamCollaborate with principal investigatorCreates a collaborative team environmentConduct close-out visitsCollect dataIdentify investigatorsSite managementSolve problems
Self Assessment :
Monitor a clinical study Interact with physicians Search literature on clinical trialsAdminister supply requestAdverse event reportingAdvise on medical perspectivesAssess site feasibilityAssess adverse reactionsArchive study documentsAssist study siteAssess subject safetyAttend investigator meetingBiomarker ResearchCoach clinical staffCollaborate with principal investigatorCollaborate with project teamCollaborate with medical teamCollect dataCollect financial data from hospitalsComplete study proceduresConduct close-out visitsConduct literature searchesConduct monitor visitsConduct post-marketing surveillance studyConduct site initiationConduct the trialConfirm protocol complianceControl dataControl protocol versionsData verificationDiscuss treatments with investigatorEthics committee submissionsForecasting of drug productIdentify investigatorsIndentify sitesInitiation visitInteract with pharmacistsInteract with physiciansProvide study site fileReport serious adverse events (SAE)Respond to audit findingsRetrieve study documentsSchedule trial visitsSite managementSolve problemsTrain on site staffUnderstand protocolsWork under specific instructions

Education

  • Clinical Research Associate Training in clinical research from Ecole SupSanté in 2005
  • D.E.S. Diploma Research Associate in Physical Science in Surface Analysis from University Claude Bernard, Lyon I, France in 1988
  • Doctor Major in Chemistry and Pharmacy from Autonomous University of Nicaragua in 1981

Training and Certification

  • Seior CRA in 2005 Training
  • Languages

    BrightOwl Assessment:
    French
    Full Proficiency
    English
    Professional Proficiency
    Self Assessment:
    Spanish
    Native
    French
    Full Proficiency
    English
    Professional Proficiency
    Portuguese
    Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Senior Clinical Research Associate (CRA)
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position
    BrightOwl employee
  • International:
    Yes

Area / Region

France

Others

Driving License
  • Yes