לוח אפשרויות קריירה - הדרך החכמה להייטק

a gloabal medical device company is looking for in house CRA
Provide support in the clinical trial operations and execution
Provide general administrative support to the clinical team.
Provide oversight on clinical documentation filling
Main responsibilities shall include (but not be limited to):


Assist the clinical team in the preparation, handling, distribution, filing including electronic filling of the clinical documentation and reports according to the scope of work and standard operating procedures.
Assist with periodic review of study files for accuracy and completeness.
Verifies investigator records and checks for consistency with the contents of sponsor files.
Assuring that study documents are accurate according to GCP requirements.
Filing and archiving study docs including uploads to eTMF.
QC uploaded documents in eTMF for OUS sites.
Assist the clinical team in tracking the Clinical Trial Supplies and maintenance of tracking information.
Assist the CTMs with clinical data cleaning by providing tracking tables, generating listings from EDC.
Ensures compliance with protocols, regulatory requirements, and good clinical practices. write/review visit reports (as applicable).
Ensures the quality of the project: verifies materials and data integrity. assists site personnel with internal audits or regulatory inspections. and perform ongoing follow-up with the in-house project team.

דרישות:
דרישות

" Excellent interpersonal, written/verbal communication skills.
" 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
" High excel knowledge