2010 - 2011 International phase 3 Oncology trial, 21 French sites, 34 patients. Performed site initiation visits with Sponsor and Clinical Trial Manager. Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products. Conducted site visits to determine protocol and regulatory compliance, and prepared required documentation. Developed collaborative relationships with investigative sites and client company personnel.
International phase 3 Oncology trial, 19 French sites, 17 patients. Performed site initiation visits with Sponsor and Clinical Trial Manager. Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products. Conducted site visits to determine protocol and regulatory compliance, and prepared required documentation. Developed collaborative relationships with investigative sites and client company personnel.
Omnicare CR
- Clinical Research Associate
2008 - 2010 International phase 2 Rheumatoid Arthritis trial, 59 French sites, 99 subjects. Review of essential documents and completion of ethics committee and regulatory submissions in association with Investigator Services, selection of sites, 2 pre-selection site visits, preparation of the initiation.
International phase 1 Nutrition trial, 1 French site (CIC), 300 subjects for this site. For this trial performed 5 co-monitoring visits. SAE and queries management.
International phase 3 Immunisation/vaccines trial, 3 to 6 French sites, 50 to 100 subjects per site. For this trial performed site initiation, monitoring and close-out visits, SAE and queries management, study and sites maintenance (creation of trackers), secondary revue of essential documents and PMF maintenance. English reports were submitted before the following visit (1 report per site and per week).
International phase 2 Immunisation/vaccines trial, 2 to 5 French sites, 50 to 100 subjects per site. For this trial performed site initiation, monitoring and close-out visits, SAE and queries management, study and sites maintenance (creation of trackers), PMF maintenance. Mentoring of a trainee CRA. 1 English report per site and per week.
International phase 3 Immunisation/vaccines trial, 2 to 5 French sites, 30 to 125 subjects per site. For this trial performed site initiation, monitoring and close-out visits, SAE and queries management, study and sites maintenance (creation of trackers), PMF maintenance. 1 English report per site and per week.
