Clinical Research Associate II – Ukraine
Job title: Clinical Research Associate II – Ukraine
Job description: Job Overview:
Here at Labcorb Drug Development we are currently recruiting for an experienced CRA.
Responsibilities will include:
- Responsible for all aspects of study site monitoring including routine monitoring andclose-out of clinical sites, maintenance of study files, conduct of pre-study and initiationvisits; liaise with vendors; and other duties, as assigned
- Ensure the study staff who will conduct the protocol have received the propermaterials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consentprocedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Ensure audit readiness at the site level
- Travel, including air travel, may be required and is an essential function of the job.
- Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
- University or college degree, or certification in a related allied health profession from an
appropriately accredited institution (e.g., nursing licensure). An equivalent amount of
experience can be substituted as appropriate.
- Thorough knowledge of ICH Guidelines and understanding of local regulatory
- Thorough knowledge of monitoring procedures
- Basic understanding of the clinical trial process
- Valid Driver’s License
- On-site clinical research monitoring experience from 1 year
- Fluent English and Ukrainian
Job date: Wed, 30 Jun 2021 22:27:31 GMT
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