Experienced Monitor / Clinical Research Associate (CRA)

Psi CRO; Illinois; On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Excellent working conditions

Extensive training

Competitive salary & benefits

Growth opportunities

Job summary

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.

Qualifications

• College/University degree in Life Sciences or equivalent.
• At least 2 years of independent on-site monitoring experience in Israel.
• Experience in all types of monitoring visits (Phases I–III).
• Oncology indications preferred.

Responsibilities

• Act as the main line of communication between the project team, sponsor, and the site.
• Build and maintain a good relationship with site staff involved in the study conduct.
• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits.
• Ensure subject recruitment targets are defined, communicated, recorded and met, and timelines are followed at site level.
• Perform source data verification and follow up on data queries at site level; review and manage study risks at 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 ISF/TMF at site level.
• Ensure quality (data integrity and compliance) at site level.
• Conduct site audit preparation visits and resolve site audit findings.
• Support preparation of Investigator newsletters and study materials.

Skills

Communication

Collaboration

Problem solving

Attention to detail

Time management

Travel ability

Hebrew & English

Education

Life Sciences degree

Tools

MS Office

Job description

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 indicationspreferred.
• Full working proficiency inHebrew 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