MARIA STAVROPOULOU

CRA II at ZEINCRO HELLAS S.A.
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Contact Information
Location
Greece, GR
Languages
  • English -
  • French -
  • Spanish -

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Experience

    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • CRA II
      • Jan 2020 - Present

      CRA II in interventional studiesTherapeutic areas: HematologyOncologyGastroenterologyNeurology/ImmunologyResponsibilities: -Verifying that all involved clinical study site personnel follow the approved protocol, Zeincro’s or sponsor’s SOPs/WPs, applicable regulations and ICH-GCP principles.Performing Pre study visits, so as to evaluate site resources and facilities and to assess site’s potential for patient recruitment.-Identification and escalation of site related issues, initiation of corrective actions and ongoing site training implementation-Monitoring activities which include: Review of investigator’s qualifications and subject eligibility, source document verification, maintenance of Investigator’s files, IP management and accountability, safety review, deviation and misconduct reporting, compliance with safety, compliance to recruitment plans, facilitating site audits and reporting monitoring visits within timelines

    • CRA conracted to Novartis
      • Jan 2017 - Dec 2019

      CRA on both interventional and non interventional studies.Therapeutic areas:Hematology/Oncology ImmunologyRheumatology Cardiology / Vascular Diseases CRA on both interventional and non interventional studies.Therapeutic areas:Hematology/Oncology ImmunologyRheumatology Cardiology / Vascular Diseases

    • Research Study Coordinator
      • Mar 2012 - Nov 2016

      -Study Coordinator:-Monitoring experience/Audit and FDA audit preparation: reviewing of source documents vs eCRF, archiving study documentation, checking of timely new ICF signing, reviewing of all SAEs and all drug accountability logs compared with IWRS reports, source documents, and drug return reports, ensuring the use of latest versions of various documents (SAE reports, counseling, diaries etc)-Maintain required records of study activity and import data in Clinical Databases from subject’s source documents-Maintain overall and subject accountability records of each Study Drug-Resolve queries that arise-Order study supplies, lab kits, dry ice for frozen samples etc-Record Toxicities that are reported in subject’s source documents-Secretarial Support (e-mails, trial set up, communication with the Scientific Council etc)-Communication with Medical Monitor Teams for the correct processing of data-Review study activities to ensure compliance with protocols

    • Greece
    • Legal Services
    • 1 - 100 Employee
    • Executive Secretary
      • Jan 2011 - Jan 2012

      office organisation, management of the firm’s directories, memberships and recruitment efforts, public relations and overseeing research programs, Human Resources, Public Relations and Ius Laboris office organisation, management of the firm’s directories, memberships and recruitment efforts, public relations and overseeing research programs, Human Resources, Public Relations and Ius Laboris

    • Executive Secretary
      • May 2008 - Apr 2011

      Executive secretary: document registration and filling, administration updating, screening/responding to incoming routine correspondence, inquiries and phone callsTaxisnet Help Desk: contact with the citizens both by telephone and e- mail in order to offer our services for matters regarding taxes and tax returns Executive secretary: document registration and filling, administration updating, screening/responding to incoming routine correspondence, inquiries and phone callsTaxisnet Help Desk: contact with the citizens both by telephone and e- mail in order to offer our services for matters regarding taxes and tax returns

    • Customer Service, Marketing,PR
      • Jun 1994 - Apr 2008

      1995-2000 Customer Service, Reception, Call center, U/S secretary, Pharmacy secretarySecretary of the Cardiological and Hypertension Department2003-2006 Marketing and Public Relations: promotion of the clinic to new target groups, optimization of various health departments, PR with clients, doctors and employees, credit accounts analysis, help desk 2006-2008 Office of finances: clients’ debts, tests, hospitalizations, medical bills, training on new programs and methods in data analysing

Education

  • American College of Greece
    Bachelor of Applied Science, Business Administration and Management
    1994 - 1998

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