Job Description
Foreign licensed M.D. wanted to work as a Sub-Investigator/Lead Study coordinator in a Clinical Research setting.
Protocol-specific training will be provided.
The Sub Investigator/Lead Study Coordinator will collect and record data per protocol requirements following the CFR section 21 and standard Good Clinical Practices and ICH Guidelines. This position interfaces between the Study Subject, Sponsor pharmaceutical company representatives, various pharmaceutical company vendors, and laboratories. The Sub Investigator/Lead Study Coordinator is expected to consent subjects, see subjects at each visit, collect patient information, record and review data following the criteria listed in the Sponsor protocol.
She/He is responsible for providing accurate documentation in compliance with good clinical practices (GCP), per ICH guidelines and the FDA Code of Federal Regulations.
The Sub Investigator/Lead Study Coordinator is one of the primary contacts and liaisons between the Sponsor Pharmaceutical Company to ensure the safety of subjects, the accuracy of data, and the operational success of the study. He or she ensures timely and accurate collection of data, entries into EDC, IVRS, and query resolution.
Company DescriptionIndependent Research facility located within Regan Medical Center.
Independent Research facility located within Regan Medical Center.
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