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 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
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.
