Clinical Research Coordinator
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Job Location:
Burlington, CO - USA
Monthly Salary:
Not Disclosed
Posted on:
7 days ago
Vacancies:
1 Vacancy
Job Summary
Posting Summary
Provide clinical research coordination and regulatory support to the Vaccine Testing Center ( VTC ) with primary responsibility for non-local clinical research studies. The Clinical Research Coordinator will support principal investigators (PIs) in protocol development preparation and maintenance of study databases (e.g. REDCap or similar platforms) including creation of data dictionaries validation rules and user access controls) study documents regulatory submissions and sponsor communications. Perform ongoing QA/QC review of study data. Responsibilities include development and maintenance of source documents case report forms (CRFs) standard operating procedures (SOPs) and regulatory binders; coordination of study trainings and updates across study teams; facilitation of routine study meetings and communications; and oversight of quality assurance/quality control (QA/QC) activities to ensure compliance with Good Clinical Practice ( GCP ) institutional sponsor and federal requirements. This position focuses on study operations documentation and regulatory compliance rather than routine on-site participant visits.
Desirable Qualifications
Demonstrated ability to work effectively as part of a team and with study subjects in a clinical research environment highly desirable. Working knowledge of Microsoft Office applications and Windows highly desirable.
Provide clinical research coordination and regulatory support to the Vaccine Testing Center ( VTC ) with primary responsibility for non-local clinical research studies. The Clinical Research Coordinator will support principal investigators (PIs) in protocol development preparation and maintenance of study databases (e.g. REDCap or similar platforms) including creation of data dictionaries validation rules and user access controls) study documents regulatory submissions and sponsor communications. Perform ongoing QA/QC review of study data. Responsibilities include development and maintenance of source documents case report forms (CRFs) standard operating procedures (SOPs) and regulatory binders; coordination of study trainings and updates across study teams; facilitation of routine study meetings and communications; and oversight of quality assurance/quality control (QA/QC) activities to ensure compliance with Good Clinical Practice ( GCP ) institutional sponsor and federal requirements. This position focuses on study operations documentation and regulatory compliance rather than routine on-site participant visits.
Desirable Qualifications
Demonstrated ability to work effectively as part of a team and with study subjects in a clinical research environment highly desirable. Working knowledge of Microsoft Office applications and Windows highly desirable.
Required Experience:
IC
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