Clinical Research Associate II (CRA II) at PSI CRO

Raanana, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

09 May, 26

Salary

0.0

Posted On

08 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research Associate II, Monitoring tasks, Site selection, Site initiation, Routine monitoring, Close-out visits, Subject recruitment, Adverse Events management, Protocol deviations management, Source data verification, Data query follow-up, Study risk management, Investigational Product handling, Study document review, TMF reconciliation, Site audit preparation

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The Clinical Research Associate II acts as the primary communication link between the project team, sponsor, and clinical sites, managing all aspects of study conduct including monitoring visits and ensuring compliance with quality standards. Responsibilities involve preparing for and conducting site selection, initiation, routine monitoring, and close-out visits while ensuring timely subject recruitment and accurate data flow.