V-Wave a lead innovation medical device company, is looking for an In House CRA (IHCRA) / CRA for the company clinical trials.
:Full time job, office based at Caesarea North Industrial Park, Israel.
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.
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 computer skills and excel knowledge
Existing experience as a CTA/IHCRA/CRA