Clinical Trial Associate

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Support

Job Category:
Professional

All Job Posting Locations:
Yokneam, Haifa District, Israel

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Clinical Trial Associate to be in Caesarea.


* Provide general administrative support to the clinical team.


* Provide support in the clinical trial operations and execution


* Provide oversight on clinical documentation filling and vendors/sites payments.

Main responsibilities:


* Set up, organize and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival


* Assuring that study documents are accurate according to ISO/ICH-GCP requirements


* Filing and archiving study documents including uploads to eTMF


* QC uploaded documents in eTMF for ILEU sites


* Assist the clinical team in the clinical documentation and reports according to the scope of work and standard operating procedures


* Support periodic review of study files for accuracy and completeness


* Support EDC data review


* Support the CTMs with clinical data cleaning by providing tracking tables, generating listings from EDC


* Organize and maintain tracking of the Clinical Trial Supplies and maintenance of tracking information


* Support the clinical team with the tracking and management of the clinical data flow such as regulatory documents, source documentation for translation, etc.


* Assist in coordination and tracking of sites and CROs payments


* Support audit preparations

Experience, skills and Knowledge Required:


* Excellent interpersonal, written/verbal communication skills.


* Fluent in English.


* At least 2 years of clinical trial experience in Pharmaceutical, Biotech, or a CRO company is required.


* Bachelor’s degree or equivalent combination of education/experience in science or health-related field required


* Working knowledge of GCP/ICH guidelines


* Proficiency in Excel

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