Clinical Research Associate

Job description:

· Monitoring clinical studies in Israel, including Monitoring visit reports (MVR) and assisting with the review of sites from the rest of the world (ROW) MVR.

· Assistance in potential subjects’ recruitment for Israel sites according to GCP guidelines.

· Clinical assistance from end-to-end– from operation to data management, TMF management, visits schedules, Protocol Deviations, AEs management, including visits at Israel sites.

· Managing all study site coordinators and study staff at Israel’s medical centers.

· Assistance in the preparation of all IRB submission documents (initial and ongoing) for the Israel sites, including amendments and annual reports.

· Support in clinical operations, including Clinical Device Inventory management, and additional required products/equipment for the conduct of the clinical study in ROW (as may be applicable).

· Ongoing data management for all clinical studies, including supervision of EDC data entry according to the study protocol and to the clinical SOPs.

Requirements:

At least one year of experience in clinical research

At least a first degree in science or engineering

CRA qualification, preferably experience as a CRA and data management

Strong English – written and verbal communication abilities

Excellent organization skills and ability to focus on details

Experience in Israel clinical submissions to IRB

Experience in a literature review

A proven ability to meet deadlines

Good relations and teamwork