Centre d'Investigation Clinique Cochin-Pasteur, Hôpital Cochin
- Coordinatrice d'études cliniques
2012 - maintenant
Set up and follow-up of clinical studies (institutional and industrial), phase I, II, III, IV, national, international and multi-center trials. Alternately investigator site or coordinator center/research leader, we are involved in all study activities from clinical trial financement to clinical trial publication.
Main activities as partner of an European consortium:
➢ Financial aspects
➢ Participating to annual meetings and reporting to the project leader
Global management activities :
➢ Collaboration with networks, preparation and lead of Clinical Trial Team meetings
➢ Selection and management of study sites and subcontractors
➢ Follow-up of countries/study sites involved in the study, coordination between partners (clinical centers, pediatrics, statistician, data manager, scientist...)
➢ Collaboration to the selection and managment of the Contract Research Organisations : definition of CRO responsibilities, financial negociation…
➢ Organisation and management of investigational centers and logistics in collaboration with the monitoring team (samples circuit, materials order)
➢ Participation to regulatory submissions (initial and amendments)
Financial activities :
➢ Obtain clinical trial financial agreement : call proposals (PHRC…), donation…
➢ Evaluation of study budgets, timelines and financial agreement/contract
➢ Financial follow up of the clinical trial and management of volunteers indemnification
Redactional activities :
➢ Conception, writing and validation of clinical protocol in close interaction with experts
➢ Writing of other study documents (ICF, volunteers diaries, laboratory manual, procedures)
Data and samples management :
➢ Creation of the eCRF with the data-manager
➢ Coordinate the movement of samples to the central laboratory
Main activities as clinical center :
➢ Local set up and follow-up of the trial
➢ Management of logistics (samples circuit, materials order, stocks)
➢ Development of recruitment strategies, recruitment follow-up, visits planning, communication with the investigators and clinical study technicians
➢ Training and coaching of the team
Our center also have an expertise for non interventional studies :
➢ Writing and validation of study document (protocole, paper CRF, ICF, Procedures) in close interaction with experts, regulatory submissions
➢ Monitoring activities :
o Initiation and close-out visits
o Formation and information of investigators and investigational team
o Archiving of regulatory, administrative and study documents
