Hélène LE BIHAN

En résumé

Entreprises

• Coalface Consultancy

  maintenant

• Indépendante - Clinical Research Associate

  2009 - maintenant • Clinical Trial feasibility study (site identification, visits and assessment of feasibility results).
  • Initiation of project: ethics committees, negotiation of the investigator and institutions contract as well as local budget split.
  • Obtaining, reviewing and processing regulatory and administrative documents from investigator sites
  • Perform the agreements with sites according to local specificities and regulation (investigator, institution and association contracts).
  • Monitoring visits including pre-study, initiation, ongoing monitoring and close out as required.
  • Performs all other sites monitoring activities (investigative site file reconciliation, Serious Adverse Event reporting, audits, inspection, study logistic and material).

• SORECLIN / Dr SPILTHOOREN - CRA

  2002 - 2009 SORECLIN (Dr SPILTHOOREN) in collaboration with EURAXI PHARMA
  Clinical Research Associate/ Study Nurse
  March 2002 - May 2009
  
  - Coordination, Organization and realization of all circuit of clinical trials phases II, III and IV for investigators group in Normandy:
  
  • Participating in feasibility surveys
  • Participating Investigator meeting
  • Investigator recruitment, Investigators network extension
  • Administrative and logistics management of clinical studies
  • Investigator’s help in administration and logistic of clinical studies, responsibilities includes site coordination under investigator’s management, CRF completion (Phosco, Inform, IRDE)
  • Patients reception and follow-up
  • Investigators assistance during visit
  • Data transcription into the case report form
  • ECG centralized or not…IVRS, all protocol’s requirements could be done by Study- Nurse
  • Quality Insurance checking with Sponsor’s CRAs
  • Preparation meetings, management of the equipment and treatment, updating of data in e-CRFs, Data Clafications Forms management, participation in monitoring and audits visits;
  • Patients pre-screening, monitoring and verifying groups criteria, randomization of the patients, setting appointments for supplementary exams, training in the filling of e-diaries;

• PRINTEMPS - Financial General Assistant

  Paris 1986 - 2002 Management of a company of 20 people in the retail business.

Formations

• Université Paris 6 Pierre Et Marie Curie

  Paris 2008 - 2009 DIU-FARC-TEC

• ICS Bégué

  Paris 1982 - 1986

Réseau

• Benoît SPILTHOOREN

• Bruno COMBES

• Fatima DAHMANI

• Isabelle GAUDIN

• Laurent AFONSO

• Mina LOUAHDI

• Sannaa EL MAAROUFI ELIDRISSI

• Sophie PAUMEL

• Stéphane COURTIAU

• Stéphanie SCHNEIDER