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Clinear Research Inc, Mauritius
- Owner of Clinear Research / Freelance CRA
2015 - maintenant
Responsibilities :
France/ Belgium/ UK
Remote monitoring services.
Mauritius:
Selection and prequalification of all the partner sites of the country.
Creation of a CV library of the Clinical Research Physicist
Establishment of a Grid of Overcost fee with the collaboration of some of the major Mauritian actors in Clinical Research
Reunion/ Mauritius Islands:
Clinical Trials undertaking : Monitoring including site selection, Start-up activity, International and National Study Management.
Investigation and Management in Clinical Research
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PAREXEL International
- Clinical Research Associate
Paris
2011 - 2015
Responsibilities :
Clinical trials monitoring in accordance with the ICH Guidelines, the current monitor guidelines and SOPs including identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring at sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis and performing site close-out visits
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Parexel
- Senior Clinical Research Associate
Paris
2011 - 2015
• Clinical Research Associate, PAREXEL International, Paris, France, from September 2011
THERAPEUTIC AREA EXPERTISE
Oncology : Thyroïd cancer, Renal Cancer, Breast Cancer, Lung Cancer.
Gastro Enterology : Crohn’s disease.
Pulmonology : Bronchiestasis.
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Clinical Research Associate, I3 Pharmaresourcing
- Clinical Research Associate
2010 - 2011
Responsibilities :
Site monitoring visits, management of cut off timelines, management of queries and SAE, investigational products management, management of Central Files, mentoring junior CRAs.
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i3 Research
- Clinical Research Associate
2010 - 2011
Site monitoring visits, management of cut off timelines, management of queries and SAE, investigational products management, management of Central Files, mentoring junior CRAs.
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Ambroise Paré Hospital
- Project Coordinator
2008 - 2009
Ambroise Paré Hospital (Gastroenterology department),
* Responsibilities :
* Gathering all projects information: schedules, data requests, assignment task, and project meetings.
* Working with projects team to understand and assist with tracking all work, task and project assignments.
* Working with members of the department to define problems and clarify study objectives. Training of clinical team members.
* Coordinating with other hospital departments to obtain data and ensure data integrity.
* Gathering and compiles documentation on standard data sets.
* Conducting or coordinating special analytic projects as assigned.
* Negotiating Research Site Clinical Study's budget and preparing contracts by :
* Reviewing industry study start-up basic contract content : ``indemnification; other agreements including data use, confidentiality.
* Developing study budget presentations : Based on objective market data; subject vs. visit based.
* Anticipating protocol amendments and procedure changes; financial checks and balances.
* Assessing protocol feasibility and resource needs : by Looking for hidden costs; study start-up to final query resolution.
* Anticipating any limiting factors for study success and establish a preventive actions plan on a timely manner. ;
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Ambroise Paré Hospital
- Clinical Project Coordinator
2008 - 2009
Gathering all projects information: schedules, data requests, assignment task, and project meetings.
Working with projects team to understand and assist with tracking all work, task and project assignments.
Working with members of the department to define problems and clarify study objectives. Training of clinical team members.
Coordinating with other hospital departments to obtain data and ensure data integrity.
Gathering and compiles documentation on standard data sets.
Conducting or coordinating special analytic projects as assigned.
Negotiating Research Site Clinical Study’s budget and preparing contracts by :
• Reviewing industry study start-up basic contract content : “indemnification; other agreements including data use, confidentiality.
• Developing study budget presentations : Based on objective market data; subject vs. visit based.
• Anticipating protocol amendments and procedure changes; financial checks and balances.
• Assessing protocol feasibility and resource needs : by Looking for hidden costs; study start-up to final query resolution.
Anticipating any limiting factors for study success and establish a preventive actions plan on a timely manner.
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Ambroise Paré Hospital
- Study Coordinator
2007 - 2008
Ambroise Paré Hospital (Gastroenterology department),
* Responsibilities :
* Conducting site initiation and close out visits, attending monitoring visits from CRAs, patient screening, data collection and data entry in paper or eCRFs, AE/SAE reporting, following up and solving data queries, attending CRA meetings, attending site audits, preparation of biological samples, management of study drug, management of Investigator Site Files. ;
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Hospital Ambroise Paré
- Study Cordinator
2007 - 2008
Conducting site initiation and close out visits, attending monitoring visits from CRAs, patient screening, data collection and data entry in paper or eCRFs, AE/SAE reporting, following up and solving data queries, attending CRA meetings, attending site audits, preparation of biological samples, management of study drug, management of Investigator Site Files.
