At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to its employees by providing competitive rates and compensation, a comprehensive employee benefits programs, attractive working conditions, and the chance to build and explore a career opportunity by offering professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Work with sponsors during the study start-up process to prepare the regulatory documents and maintain the studies’ regulatory binders throughout duration of study through close out including version control.
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Work with the Institutional Review Board to submit initial study applications, amendments, continuing reviews, adverse event reports and other submissions.
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Provide regular updates to the Regulatory and Operations team members on where studies are in the review/start-up process, monitoring outcomes, and close out preparation.
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Maintain the delegation of authority logs and regulatory documentation for each study and ensure study staff training on each protocol.
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Work with sponsors to set up site initiation visits, monitoring visits and study close-out visits and prepare post-visit documents.
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Maintains tracking for all protocol related paperwork and collects documents from sponsors for protocol submission and maintenance. |
Coordinates FDA submissions and prepares for all research audits. |
Must have at least 3-5 years of related experience.
Biology, Research, Public Health, Business Administration, Healthcare Administration or related field
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