-
Quintiles
- Senior Clinical Research Associate
Durham
2010 - maintenant
Study Therapeutic area / number of managed sites :
Oncology: Non-Small Cell Lung Cancer / 07 sites
Oncology: Non-Small Cell Lung Cancer / 01 site
Oncology: Non-Small Cell Lung Cancer / 16 sites
Central nervous System: Non-Ischemic Stroke / 03 sites
Central nervous System: Multiple Relapsing Sclerosis / 05 sites
Gastro-enterology: Crohn’s Disease / 04 sites
Gastro-enterology: Ulcerative Colitis / 02 sites
Gastro-enterology: Crohn’s Disease / 02 sites
Gastro-enterology: Ulcerative Colitis and Crohn’s Disease (open label) / 05 sites
Cardio-Vascular System : Acute Coronary Syndrom / 02 sites
- Study Initiation: Scheduling of the visit, site staff training, initiation report writing, ICH-GCP training for the investigators. Collection of various regulatory document (CV, FDA, FDF and EU forms, Confidential Trial Agreement …)
- Full monitoring activities: site management, ICF verification, Source Data Verification, query resolution, ISF check and update, AE/SAE reporting to PhV, monitoring report writing, IP accountability, temperature excursion/deviation process, central labs, management of the over-costs and of the investigator fees. Follow up of the study in each sites in accordance with protocol, SOPs (both internal and study specific), GCP and regulatory requirements.
In close contact with site to resolve any issue regarding patient safety or protocol.
Management of the site overcost and PIs fees.
- Close-out visits: ISF review, IP reconciliation and if applicable return of the unused IPs to the sponsor for destruction, explanation of the archiving obligation and the possibility of audits by regulatory authorities.
- Update of all trackers/forms: updates of recruitment, financial, study staff specifics trackers and monthly updates of personal trackers (visits, trainings, time dedicated to each protocol, reimbursement of the travelling costs …)
-
HCL Pôle méthodologie en recherche clinique
- Clinical research Associate, project coordinator
2009 - 2010
Phase III Treatment / Ophthalmology : Age Related Macular Degeneration. 47 sites
Health Care study / Ophthalmology : Uveitis etiological diagnosis. 18 sites
In charge of the initiation visits: Forward planning and organization of the visit, explanation of the protocol and study procedures training, initiation report writing, ICH-GCP training for the investigators.
- Full monitoring activities for regional sites: site management, ICF verification, SDV, query resolution, ISF update, AE/SAE reporting, monitoring report writing, IP accountability, labeling process. In accordance with protocol, SOP, GCP and regulatory requirements.
- Close-out visits: ISF review, SDV check, IP reconciliation, explain the obligation for archiving CRF, DCF and ISF
- Online clinical trial registration, submission to CNIL & CCTIRS, submission and protocol change requests for AFSSAPS & ethics committees.
- Writing of study documents (case report form, investigator’s flyer, specific study procedures, newsletters, monthly report for each site, etc.)
- Search for and selection of different study-related providers: printers, e-CRF designers, medical equipment, suppliers, carriers, etc.
- In direct contact with the main investigator and support to investigators and pharmacists of all sites.
- Feasibility and budget management during the study.
- Clinical research Network with more than 300 contacts counting investigators (PU-PH, PH), pharmacists, CRAs …
- Consistency control and test of the eCRF and studies databases
-
Laboratoire Dermscan
- Clinical Research Associate, Project Manager Assistant
2008 - 2009
Therapeutic Area :
Dermatology : Psoriasis treatment / Atopic dermatitis treatment / Skin burn
- Full monitoring activities
- Support to staff involved in the study (investigators, technicians, project managers, etc.)
- Writing of Case Report Forms and other forms (AE and SAE, inclusion, schedule of the visits follow-up forms)
- Delivery of GCP-ICH trainings, reviewer on different documents: protocols, final reports.
-
Sanofi pasteur
- Project Manager Assistant
Lyon
2005 - 2007
To find a new process for Pharmaceutical manufacturing Areas decontamination (National project)
- Implementation / Follow-up / Management of trials in a multifactorial experiment.
- Treatment / Result analysis.
- Interaction with different departments: QC/QA/suppliers/R&D/Production.
- Writing specifications, protocols and trial reports related to the project.
- Full-scale demonstration of process performance.
- Production assistance (worker’s training / writing procedures / inventory management).
