PRAHS Clinical Study Specialist (Site Support Services) - São Paulo in United States
The Clinical Study Specialist performs administrative tasks for the proper support of clinical research studies. At study sites works with site team to support studies, administratively, to be initiated, conducted and/or completed in accordance with study and site specifications, processes, and good clinical practice.
Pre-screening and screening phase:
- Support the submission of the protocol and other documents to the ethics committee (EC) for approval and the development and maintenance of files and binders.
During trial conduct:
Assist with scheduling patient visits.
Transcription of source document datapoints into EDC including query response according to the timelines and which can be clearly accessed in source documents.
Submission of applicable trial documents to the ethical and regulatory entities.
Archive and maintenance of the regulatory folders and binders.
On-site and off-site monitoring visit support, such as communication with CRAs for scheduling visits, providing access to site documentation and supplies to CRA reviews, accommodate meetings with site staff, etc.
Audit support, as needed.
Manage meetings, as needed.
At closure and follow-up:
Support scheduling of follow-up visits.
Completion of queries and CRFs in order to achieve DBL in the expected timeline.
Support the resolution of any open action item at the site.
Support with study close-out visits.
Bachelor's degree in a Science related field.
Experience working with administrative activities in clinical trials.
Read, write and speak advanced English; fluent in host country language required.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/