Clinical Research Associate II (CRA II)

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 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 drivers 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.

Remote Work :

No

Employment Type :

Full-time