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
· 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