French-speaking CRA (medical device)

Alpha Tau Medical is a dynamic start-up company developing an innovative new cancer treatment that is already being tested in dozens of medical centers around the world with the potential to help millions of patients. Alpha Tau has made news globally for its ground-breaking treatment for skin and pancreatic cancers and continues to work on development of treatments for additional types of cancer.

The CRA is responsible for supervising Alpha Tau's clinical trial sites to ensure proper conduct and documentation, as well as accuracy and competence of the clinical data in the EDC by performing source data verification with the site trial documents. This position is based in our office in Jerusalem.

Responsibilities

Ensure the investigators and site study teams adhere to applicable regulations, ICH/GCP guidelines, local policies, and the study’s standard operating procedures.

Working independently and actively to coordinate and perform all types of site visits including, but not limited to, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits. Submit written reports of visits activities.

Assist with document submissions to local authorities

Ensure clinical data is accurate and complete (source data verification) and ensure data query resolution is achieved promptly.

Coordinate logistics and administrative tasks related to the study (shipments, study supply, meetings, etc.)

Perform additional duties as assigned.

Up to 20% travel required.

Qualifications

• Bachelor's Degree in a health sciences, medical sciences, or nursing.
• 2+ years of prior clinical research experience (as CRA or SC)
• French speaker
• Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data.
• Exceptional communication, collaboration, organizational and time management skill.
• Experience in the medical device industry preferred.