Experienced Monitor / Clinical Research Associate (CRA) - PSICRO

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 

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.

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 

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.