JENNIFER RUOS-DOSIO

• Managed studies including CRA coordination, invoicing, document development, TMF maintenance, and meeting facilitation.
• Regulatory submissions (France and Europe) initial and amendment on CTIS platform and RIPH platform (ethicss committee and competent authorities).
• Hospital contract management.
• Third-party management (eCRF, lab kit provider, sample shipment...).
• Communicated with sites, CRA, and sponsor via phone and email to ensure alignment and progress.
• Follow-up of recruitment
• Developing the essential documents of trials
• Assistingg management of studies (investigator selection, analysis of potential patient recruitment).)

Therapeutic areas: Hematology, Cardiology, Nephrology, Oncology, Pediatrics

• Management of studies (Initiation, Monitoring, Close-out, Invoicing). Monitoring on site and remotely.
• Submission initial and amendment (ethics committee and competent authorities).
• Hospital contract management.
• Third-party management (eCRF, lab kit provider, sample shipment).
• Communication with sites and sponsorss by phone and email.
• Creating and formatting the investigator Site File.

Therapeutic areas: Hematology, Cardiology, Nephrology, Oncology, Pediatrics

• Checked electronic data capture systems for integrity and compliance.
• Communication with sites.
• Translation of documents for customers, French to English (investigator CVs, etc.)
• Updating investigator files.

Therapeutic areas: Oncology

• Multicentric study
• Monitoring for a phase III study in neurology field: Parkinson disease
• Epidemiological study: multicentric investigational research in hepatology (all hepatitis), data completion for e-CRF.

• Pre-clinical experimental research in murine model in asthma (drug testing)

• Pain and RCPG Unit Pre-clinical experimental research in mouse models in pain field – Measure of selective threshold (dorsal root)