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Clinical Research Associate II (CRA II)
full-timeRaanana

Summary

Location

Raanana

Type

full-time

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About this role

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Clinical Research Associate at PSI, you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

  • Act as the main line of communication between the project team, sponsor, and the site
  • Build and maintain a good relationship with the site staff involved in the study conduct
  • Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
  • Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
  • Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
  • Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
  • Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
  • Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
  • Ensures quality (data integrity and compliance) at site level
  • Conduct site audit preparation visits and resolve site audit findings
  • Participate in study site audits and client onsite visits, as required
  • Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
  • Conduct project-specific training of site investigators
  • Support preparation of Investigator newsletters
  • Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
  • Support preparation of draft regulatory and ethics committee submission packages
  • Support collection of IP-RED packages at site/country level
  • Facilitate review and reconciliation of the study TMF on country and site levels 

Qualifications

  • ​​​​​College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • 2-4 years of independent on-site monitoring experience in Israel and knowledge of the local clinical research environment required
  • Experience in all types of monitoring visits, in phases I-III
  • Experience with Oncology indications preferred.
  • Full working proficiency in Hebrew and English
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • ·Attention to detail, organizational and time-management skills
  • Valid driver’s license and ability to travel 

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

We offer:

  • Excellent working conditions
  • Extensive training and friendly team
  • Competitive salary and benefits package
  • Opportunities for personal and professional growth

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Other facts

Tech stack
Clinical Research,Monitoring,Communication,Collaboration,Problem-Solving,Attention to Detail,Organizational Skills,Time-Management,Data Verification,Regulatory Submission,Training,Relationship Building,Risk Management,Site Audits,MS Office Proficiency,Hebrew Proficiency

About PSI CRO

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.

PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.

PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.

PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.

http://www.psi-cro.com

Team size: 1,001-5,000 employees
LinkedIn: Visit
Industry: Pharmaceutical Manufacturing

What you'll do

  • As a Clinical Research Associate, you will act as the main line of communication between the project team, sponsor, and site, ensuring quality standards are maintained. You will prepare and conduct monitoring visits, manage study risks, and ensure compliance with protocols.

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Frequently Asked Questions

What does a Clinical Research Associate II (CRA II) do at PSI CRO?

As a Clinical Research Associate II (CRA II) at PSI CRO, you will: as a Clinical Research Associate, you will act as the main line of communication between the project team, sponsor, and site, ensuring quality standards are maintained. You will prepare and conduct monitoring visits, manage study risks, and ensure compliance with protocols..

Why join PSI CRO as a Clinical Research Associate II (CRA II)?

PSI CRO is a leading Pharmaceutical Manufacturing company.

Is the Clinical Research Associate II (CRA II) position at PSI CRO remote?

The Clinical Research Associate II (CRA II) position at PSI CRO is based in Raanana, Center District, Israel. Contact the company through Clera for specific work arrangement details.

How do I apply for the Clinical Research Associate II (CRA II) position at PSI CRO?

You can apply for the Clinical Research Associate II (CRA II) position at PSI CRO directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about PSI CRO on their website.