A leading company in the brain health technologies is looking for an experienced 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 companys 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.
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.
Requirements:
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.
Availability to travel abroad when needed (quarterly).
Availability to work with the EU/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.