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Experienced Monitor / Clinical Research Associate (CRA)

PSICRO · Ra'anana, Center District, il
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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 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.

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