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PSI CRO

Experienced Monitor / Clinical Research Associate (CRA)

Ra'anana, Center District, IL · On-site · Full-time · Clinical

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About the role

Clinical ResearchCommunication
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. 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  - ​​​​​College/University degree in Life Sciences or an equivalent combination of education, training & experience - At least 2 years of independent on-site monitoring experience in Israel and knowledge of the local clinical research environment are 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  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 growthMake 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.