Our company is a Jerusalem-based clinical-stage company that is developing non-invasive diagnostic devices to assess peripheral artery disease (PAD).
PAD is commonly associated with diabetes and impacts about 230 million people worldwide.
We are seeking a motivated Clinical Research Associate (CRA) with passion to patient care and experience in the conduct of clinical studies in the US, Europe and Israel.
The CRA will play a crucial role in the successful execution and monitoring of our pivotal clinical trials and will be responsible for overseeing the clinical trial activities.
The CRA will report to our VP RA/ QA /Clinical.
Key Responsibilities:
1. Assist in the preparation of study-related documents (e.g., study protocols, Case Report Forms, informed consent forms) and in the submission of the studies for approval by the Ethics Committees/Institutional Review Boards.
2. Perform site visits (initiation, monitoring, and close-out as well as site qualification visits to identify appropriate clinical sites) in US, Europe and Israel. Some visits may be performed remotely.
3. Build and maintain strong relationships with investigators, site staff, and study coordinators.
4. Ensure adherence to study protocols, companys procedures (SOPs), GCP, and applicable regulatory requirements as well as to the examination procedure with the investigational device.
5. Ensure the quality of the clinical data collected at the study sites by verifying its accuracy and completeness (source data verification, review of the CRF/EDC).
6. Manage and track essential study documents and maintain the Trial Master File.
7. Identify and report protocol deviations and other study-related issues, as applicable, and assist in their timely resolution.
8. Conduct investigator meetings and training sessions, as applicable.
Requirements: Bachelor's degree in a life science or related field; advanced degree preferred.
Minimum of 3 years of experience as a CRA in the medical device industry.
In-depth knowledge of GCP, FDA and EU regulations, and relevant international standards and regulatory requirements.
Experience in clinical trial monitoring, including conducting of on-site monitoring visits, data verification and working with Electronic data Capture tools, and regulatory compliance.
Excellent communication skills.
Excellent organizational skills and detail-orientation.
Ability to work independently and as part of a team.
Flexibility and open-mindedness.
Proficiency in Microsoft Office and common clinical research software systems.
Fluency in English (both verbal and written); additional languages are an advantage.
Willingness to travel domestically and internationally (up to 40% of the time), and to work in the companys office in Jerusalem when not travelling.
This position is open to all candidates.
