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Scimega Research
- Program Specialist (Clinical operations oversight)
2020 - maintenant
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Scimega Research (Montreal, Canada)
- Clinical Trial Leader
2016 - maintenant
Site selection and study start-up activities
o Organize site start-up activities
o Review investigator contracts and budgets
o Attend investigator meetings
Study management and maintenance of client relationships
o Organize periodic meetings with our clients
o Prepare and distribute periodic progress reports to clients
o Identify potential risks to the conduct of the study and pro-actively identify mitigating actions
Supervision of Scimega CRAs
o Plan and organize initial training for newly hired CRAs
o Ensure that all CRAs are adequately trained at all phases of the project.
o Conduct periodic meetings with the CRAs to discuss the progress of each trial
o Review site visit reports and follow-up letters
o Act as support for junior CRAs and conduct co-monitoring visits
Site management
o Conduct investigational site selection, initiation, routine monitoring and termination visits
o Monitor study centers in accordance with International Conference on Harmonization Good Clinical Practice (ICH GCP)and Sponsor SOPs
o Serve as liaison between the Sponsor and the Investigator
o Account for study drug storage, study drug usage, including reconciliation and destruction
o Review the Investigator Study Files as required to maintain them up-to-date and accurate
o Review adverse events for accurate recording and reporting
o Submit written reports following site study visit
o Act as a resource for investigational site queries
o Participate in project team meetings and conference calls
http://scimega.com/
We are a Canadian specialty CRO with a singular focus on oncology. We play a vital role in improving the speed and efficiency of oncology clinical research through a deep understanding of the needs of sponsors, investigators and patients.
Our mission is to attract cutting-edge oncology compounds and clinical trials to Canada by improving site selection and patient recruitment, and accelerating the conduct of oncology clinical trials.
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Scimega Research (Montreal, Canada)
- Senior Clinical Research Associate, Oncology
2015 - 2016
• Study start-up activities
• Conduct investigational site selection, initiation, routine monitoring and termination visits
• Monitor study centers in accordance with International Conference on Harmonization Good Clinical Practice (ICH GCP)and Sponsor SOPs
• Serve as liaison between the Sponsor and the Investigator
• Account for study drug storage, study drug usage, including reconciliation and destruction
• Review the investigator file as required to maintain up-to-date and accurate the Investigator Study Files
• Review adverse events for accurate recording and reporting
• Submit written reports of investigation site findings following site study visit
• Act as a resource for investigational site queries
• Review investigator contracts
• Act as support for junior CRAs
http://scimega.com/
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Scimega Research
- Clinical research associate
2012 - 2015
www.scimega.com
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LA-SER Group
- Clinical research associate
2011 - 2012
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ICTA PM
- Attachée de recherche clinique
CHALAIS
2009 - 2011
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New England Biolabs
- Stagiaire en recherche
2008 - 2009
Stage de 8 mois en recherche fondamentale dans la division ARN. Projet: développement de nouveaux outils pour la localisation d'ARNm dans des cellules de mammifères
