Experienced Monitor / Clinical Research Associate (CRA)

About the role

PSI, a Contract Research Organization with more than 30 years in the industry, is hiring an experienced Monitor / Clinical Research Associate (CRA) in Ra'anana. You will carry out monitoring tasks on clinical studies across different therapeutic indications, acting as the main link between the project team, sponsor and site.

Key responsibilities

• Build and maintain good relationships with site staff and act as the main communication channel between project team, sponsor and site
• Prepare, conduct and report site selection, initiation, routine monitoring and close-out visits
• Ensure subject recruitment targets and project timelines are met at site level, and keep sites informed on adverse events and protocol deviations
• Perform source data verification, follow up data queries and review and manage study risks at site level
• Oversee handling, use, accountability, reconciliation and return of investigational products and study supplies, and reconcile the Investigator Site File (ISF) / TMF
• Ensure data integrity and compliance, prepare for and take part in site audits and client visits, and support site investigator training
• Support regulatory and ethics committee submissions, IP-RED packages, and draft Investigator newsletters
• Help Site Management Associates maintain tracking systems and ensure document and supply flow between site and laboratory, reviewer and warehouse

Required profile

• College or university degree in Life Sciences, or equivalent education, training and experience
• At least 2 years of independent on-site monitoring experience in Israel, with knowledge of the local clinical research environment
• Experience in monitoring visits across phases I-III
• Experience with oncology indications preferred
• Full working proficiency in Hebrew and English
• Valid driver's license and ability to travel

Required skills

• Proficiency in MS Office applications
• Planning, multitasking and teamwork
• Communication, collaboration, problem-solving, attention to detail, organization and time management

What we offer

• Extensive training and a friendly team
• Competitive salary and benefits package
• Opportunities for personal and professional growth