Israel · Full time · Entry-level

About The Position

and passionate CRA. You will join a dynamic and fast-paced environment and work with cross-functional teams to design, build and roll-out products that deliver the company’s vision and strategy.

The primary role will be to provide overall support to the clinical affairs Manager and serve as a point of contact to the company's internal clinical queries in addition to performing monitoring to ongoing studies. You will administer, monitor, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). 

Primary Roles & Responsibilities

The CRA will be involved in most Clinical activities:

·         Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial

·         Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.

·         The set up and maintenance of the Trial Master Files (TMF) and additional general study filing.

·         Managing and maintaining study documents & trial supplies

·         Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.

·         Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments.

·         Assist with collating, tracking & shipping CRFs & data queries

·         Updating and writing Clinical SOPs

·         developing and writing trial protocols

·         designing data collection forms, (CRFs);

·         liaising with doctors/consultants or investigators on conducting the trial;

·         setting up the trial sites, which includes ensuring each center has the trial materials and supplies and training the site staff to trial-specific standards;

·         monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis;

·         verifying that data entered on to the CRFs is consistent with patient clinical notes (SDV);

·         writing visit reports and filing and collating trial documentation and reports;

·         Close out of trial sites on completion of the trial;

·         archiving study documentation and correspondence;

·         preparing final reports and occasionally manuscripts for publication.

Essential skills & experience:

·         Understand clinical trial processes and needs

·         High level of written and spoken English and Hebrew -a must.

·         Excellent written and oral communication skills

·         Excellent attention to detail

·         Pro- active, flexible and able to multi-task

·         Quick to learn

·         Excellent organizational skills

·         Self-motivation

·         Team player

·         Excellent time management

·         IT literacy, particularly in Excel Word, and PowerPoint

·         JMP knowledge is an advantage

·         Availability to travel to the US if needed (quarterly)

·         Availability to work with the US if needed considering the time difference

·         Experience with regulatory clinical submissions in Israel and abroad

·         Experience with creating and monitoring of Electronic CRF

·         Experience with Audit preparation is an advantage

Desirable Education and experience background:

·         University degree in health sciences or related field

·         2-3 years’ experience of working as a CRA for the Medical Device Industry

·         Knowledge of the Industry/ Clinical trial process/ experience in Quality assurance

·         GCP and CRA certificate

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