Clinical Research Associate

MARGARETTHA PIERRE

OBJECTIVE

Clinical Research/Epidemiology/Public Health

Preferred Locations: North America, South America, Europe. Willing to travel as necessary.

EXPERIENCE

****-********* ** Diagnostics-Infectious Disease Quebec, Qc

Clinical Research Associate/Core team Member

Planification, negociation, conduct, monitoring and redaction of clinical investigation reports ( CTA, protocol, FA, taining manual, etc)

Provide clinical and technical support in product development activities, reglementary affairs soumissions, ect.

Selection of sites and principal investigation (with team)

Conception of CRF

Data analysis

Liaison between principal investigator and team

Coordination and planification of study material at sites

Built the training program and train the sites

Surveillance of the course of the study

Represent the medical department within the product development team (Core Team)

Responsible of all deliverables of the medical function

Decisional power on behalf of the medical function

Liaison between the Core Team and the medical function

Interaction with other responsibles of other functions to coordinate the deliverables

Team Coordination

2008–2010 Les Cliniques Universitaires de St-Luc Brussels, BE

(24 months)

Master’s student

Literature review

Data collection and data management of target patients in the study

Statistical analysis

Thesis redaction

Presentation of the study (retrospective study on the side effects of Nevirapine)

2007–2008 Genizon BioSciences Montreal, QC

(12 months)

Clinical Research Assistant

Inform all interested volunteers on current studies.

Data collection in the Direct Recruitment program ensuring their legibility to one of the studies ongoing according to the SOPs.

Follow-up of recruited volunteers.

Preparation of all documents (consent form, pamphlet of the study, health form) required for the nurse in charge.

2007 Montreal Neurological Institute Montreal, QC

(8 months)

Research Assistant

Project with Dr. Andermann: Action Myoclonus Renal Failure Syndrome (degenerative genetic disease).

Data collection of the patients genetic history to create a family tree in the Progeny program.

DNA extraction of those patients in the purpose of performing a gene screening.

Interview of patients under medication to monitor their health evolution and the regain of their motor capacity.

2005-2007 CIDIHCA -Montreal Montreal, QC

(24 mois)

Volunteer

Organisation of cultural events/Administrative and relational work.

2004 Health Center Queens Elizabeth Montreal, QC

(3 mois)

Volunteer (osteoporosis department)

Classification of files (administrative work).

Contacting regular visitors concerning future conferences on osteoporosis.

EDUCATION

2008–2010 Université Catholique de Louvain Brussels, BE

Master in Biomedical Sciences, concentration in Clinical Sciences

Les Cliniques de St-Luc (University, medical faculty).

Clinical option / Infectious Disease, HIV.

2009–2010 Ludwig Maximilians Universität Munich, DE

Certificate ICH-GCP.

Klinikum Grosshadern (University Hospital).

Concentration in Clinical Epidemiology.

2005–2008 Concordia University Montreal, QC

Bachelor in Science.

Biology/ specialization in Cell and Molecular Biology.

PUBLICATIONS

63rd American Academy of Neurology Annual Meeting, April 9 through April 16, 2011, at the Hawaii Convention Center in Honolulu, HI.

[IN3-1.003] Founder Effect in French Canadian Action Myoclonus-Renal Failure (AMRF) Families: Genealogical and Molecular Approaches

SKILLS

Languages

Mother tongue: French.

Other languages: English (advanced), Haitian Creole (advanced),

Spanish (intermediate), German (beginner).

Professional skills

Experience in Project Management

Data analysis

Knowledge in Regulatory Requirements (GFP, GCP, ISO, ect.)

Applied knowledge in Molecular Diagnostics

Certificate in Financing of Sustainable Development Projects

Good knowledge of laboratory procedures

ICH-GCP trained, SOP knowledge

Motivation, Innovation

Presentation and communication skills

Adaptability to different environments

Computer skills

Office Suite (Word, Excel, Powerpoint, Access), Lotus Notes, Internet, SPSS, NCSS, Progeny.

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