Clinical Research Associate (CRA)

New Phase is seeking an experienced and detail-oriented Clinical Research Associate (CRA) to join our team.

The ideal candidate will have 3-5 years of experience in conducting clinical trials in the medical device field across Israel, and the United States.

Key Responsibilities:

1. Clinical Trial Management:
2. Assist in the planning, execution, and monitoring of clinical trials for medical devices, ensuring adherence to study protocols, regulatory requirements, and company SOPs.
3. Support the coordination of clinical trials across Israel, and the U.S., ensuring consistent trial execution.
4. Participate in site selection, initiation, monitoring, and closeout activities in compliance with ICH-GCP guidelines, FDA, and other relevant regulatory bodies.
5. Site Management:
6. Establish and maintain strong working relationships with clinical sites, investigators, and study coordinators.
7. Monitor site performance to ensure proper enrollment, data collection, and reporting according to the study timeline.
8. Conduct site visits, including site qualification, initiation, interim monitoring, and closeout visits, to ensure the integrity of clinical data.
9. Regulatory Compliance:
10. Ensure trial activities comply with local and international regulations, including FDA and Israeli Ministry of Health guidelines.
11. Prepare and submit regulatory documents and ethics committee submissions.
12. Stay informed of changes in regulatory requirements and industry best practices.
13. Data Management:
14. Review clinical trial data to ensure accuracy, completeness, and quality, including CRFs (Case Report Forms) and eCRFs.
15. Collaborate with data management team to resolve data discrepancies and ensure timely data entry and database lock.
16. Documentation and Reporting:
17. Prepare and review monitoring visit reports and other study-related documentation.
18. Assist in the development and review of study protocols, investigator brochures, and study manuals.
19. Provide updates status reports and timelines.
20. Team Collaboration and Training:
21. Collaborate with cross-functional teams, including regulatory affairs, and data management, to support the success of clinical trials.
22. Participate in investigator meetings, conferences, and training sessions.

Qualifications:

1. Education: Bachelor's degree in life sciences, nursing, or a related field. A Master’s degree is a plus.
2. Experience: Minimum of 3-5 years of experience as a CRA in the medical device industry. Working in a startup environment is a plus.
3. Knowledge: Strong understanding of clinical trial processes, ICH-GCP guidelines, FDA regulations, and Israeli Ministry of Health requirements.
4. Skills:
5. Good project management and organizational skills.
6. Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
7. Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
8. Ability to travel across regions to monitor clinical sites.

Additional Requirements:

1. Fluency in English is required.
2. Ability to work independently and manage multiple tasks with attention to details.