Experienced Monitor / Clinical Research Associate (CRA)

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.

Job Description

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

• 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

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.

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.