Jean-Michel GRELLARD

En résumé

Entreprises

• Freelance - Freelance CRA

  2016 - maintenant Freelance clinical research Consultant : MUCAALT trial (CHU de Caen) ; BBEST study (GALENUS- Laboratoire ACER).  Participation in protocol redaction and other clinical trial related documents (inform consent, CRFs, amendements ...).  Protocol review and submission; selection and validation of investigator sites;  Start-up of clinical trial (financial contract, trial costs evaluation);  Remote monitoring or punctual monitoring, studies opening and closing; audit preparation.

• Centre François Baclesse - Project manager

  CAEN 2015 - maintenant Management of a clinical research portfolio on regulatory, financial, logistical, administrative, organizational and human.
  Designing and writing clinical trial protocols and technical and patient documentation for national and international studies
  Support for medical and paramedical project leaders..

• Centre François Baclesse - Clinical project coordinator

  CAEN 2009 - 2014 Participation in protocol development, protocol redaction, CRF design and other documents; Assistance in study protocol development
  Protocol submission to the French authorities according to French regulatory requirements (ANSM, ethics committees,...)
  Feasability : selection and validation of investigator sites, CROs
  Coordination of national multicenter studies
  Start-up of clinical trial (financial contract, trial costs evaluation)
  Monitoring, site selection,studies opening and closing,on site audit preparation.
  Review of clinical trial data
  Ensuring the ordering and distribution of clinical trial drug supply
  Specialist in oncology (15 years experience): breast cancer, gastrointestinal cancer, lung, gynecological ...
  For 1 year, I have held the responsability of the clinical research department.
  Mentor for training and support for junior CRAs, nurses.
  Internal auditor
  Teacher for investigators, CRAs, nurses, medecine and pharmacy students.

• Centre François Baclesse - Clinical Research Assistant

  CAEN 1997 - 2009 Lead monitor for breast and digestive studies

Formations

• Faculte De Pharmacie De Caen

  Caen 1997 - 1997 DU recherche et développement clinique des médicaments

• Université De Caen Basse-Normandie (UCBN)

  Caen 1989 - 1996 Maîtrise de Biochimie moléculaire et cellulaire

Réseau

Pas de contact professionnel