CRA & Data management

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 to the clinical department - from operation to

data management, TMF management, visits schedules, Protocol Deviations, AE

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 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.

 Ongoing data management for all clinical studies, including supervision of EDC

data entry according to the study protocol and to the clinical SOPs.

The job requires working with worldwide CROs in different time zones.

Requirements

At least 2 years of experience in clinical research

Experience in ophthalmology/optometry is preferred

At least a first degree in science

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 writing

Good relations and teamwork