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Hospitalier

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ARC/TEC possibilité freelance
Catégorie :

Hospitalier

Date de dernière mise à jour :

5 septembre 2018

Lieu :

IDF

CV :

May 2018 - september 2018 Stryker Neurovascular dpt Levallois Perret
Freelance Clinical trial coordinator

Filing feasibility documents in eTMF
Establishment of confirmation and follow-up letters
Scoring sites
Organization of the Site Qualification Visit


2017 - 2018 Ramsay Générale de Santé Paris V
Clinique du sport – Orthopaedic surgery – Doctors Bohu, Lefèvre, Herman and Gerometta
Clinical Studies Technician (Fixed-term contract 9 months)

Daily telephone contact with patients to complete the Knee, Shoulder and leg assessment questionnaires following their operation (3000 patients) to evaluate pain level and recovery of daily activity and sport activity (operation : cruciate ligament surgery, shoulder stabilization and leg hamstring tendon) (subjective ikdc, lysholm tegner score, DASH score, quickDASH, wosi scale, ucla tegner score, ACL-RSI scale)
Improvement of the e-CRF on data display and query proposals
Entering knee status data into e-CRF (telos, GNRB, koos, objective ikdc)
Traceability of data entered with creation of a table in excel (file of 1200 patients)
Realization of statistics under excel


2016- 2017 Icon Nanterre – Clinical Research Service
Clinical trial assistant (Fixed-term contract 6 months)

Filing of the studies documents in the TMF : Trial Master File and actions items treatment (audit-QC-TMF / ISF)
Updating of investigator contacts in the database (updating of FDA1572 and FDF)
Reconciliation on payment CRAs visits on sites (financial contracts)
Sending of regulatory documents for the Start-up department (mailing in Word)
Site initiation visit : preparation of investigators’ and pharmacians’binders for Belgian and German centers
Close-out visit : archiving of documents and final payment updating (contact with the sites)


2015-2016 Quintiles Saint-Ouen – Clinical Monitoring Dpt
Clinical trial assistant lead (Fixed-term contract 1 year)

Creation and updating of the Trial Master File (TMF) (audit sponsors, FDA inspection, remediation, findings)
Follow-up of the payments of the investigators fees and the overcosts in relation with the CRAs and the centers
Participation and organization of meetings and teleconferences with the project teams and internal meetings
Submission to ethics committee
Sending of regulatory documents, forms and materials to hospitals
Adding contacts in CTMS and updating FDA1572 and FDF
Extracting batch of CRA visits cost in CTMS to establish investigators fees and overcosts of the hospitals
Close-out study : COV letter to create, final invoicing and complete filing of study documents for the sponsor
Follow-up of the vendors invoicing on People Soft Financial (PSF) with entering specific codification
and creating purchase orders
Management of the maintenance of the materials placed in the hospitals and return in due time


QUALIFICATIONS
April – August 2018 CRA training with MultiHealth group
2014-2015 Training “Business English”- Wall Street English
1998 Senior Technician Degree « Executive assistant » alternately

Remarques :

Madame, Monsieur,

J’ai intégré le secteur de la recherche clinique en 2015 en qualité de « clinical trial assistant » et j’ai récemment consolidé mes acquis par une formation d’attaché de recherche clinique.

Mes principales qualités pour réussir sur une fonction d’attaché de recherche clinique sont : ma bonne organisation alliée à une bonne gestion des priorités, ma capacité à travailler en équipe et ma polyvalence.

Je maîtrise rapidement les différentes procédures et les logiciels internes à une société.

Disponible immédiatement, je suis prête à détailler l’ensemble de mes acquis lors d’un entretien.

Veuillez agréer, Madame, Monsieur, l’expression de mes salutations distinguées.

Delphine Sourie

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