Description: |
CRA positions available to work within our Phase II-IV Clinical
Operations Teams, Early Clinical Development or through our
CoSource division directly with pharmaceutical companies. As
an experienced CRA you’ll be involved in initiation, routine &
close out visits concentrating on sites in Israel. Successful
candidates will enjoy the benefits of working for a company
that values a WORK / LIFE BALANCE!
|
|
Requirements: |
As a CRA you will manage all aspects of study site monitoring
according to SOPs, GCP, and ICH guidelines, including prestudy
qualification and initiation visits, routine monitoring,
close-out of clinical sites, and maintenance of study files.
Responsibilities include:
- All aspects of site management as prescribed in the project
plans
- Recruitment of potential investigators, preparation of EC
submissions, notifications to regulatory authorities, translation
of study-related documentation, organization of meetings and
other tasks
- Negotiation of study budgets with potential investigators and
collaboration with Covance legal department with statements
of agreements
- Serious Adverse Event (SAE) reporting, production of
reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and
resolution against established data review guidelines on
Covance or client data management systems
|
|
|