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.
Short Description
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.
Work with the Institutional Review Board to submit initial study applications, amendments, continuing reviews, adverse event reports and other submissions.
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.
Maintain the delegation of authority logs and regulatory documentation for each study and ensure study staff training on each protocol.
Work with sponsors to set up site initiation visits, monitoring visits and study close-out visits and prepare post-visit documents.
Maintains tracking for all protocol related paperwork and collects documents from sponsors for protocol submission and maintenance.Â
Coordinates FDA submissions and prepares for all research audits.
Experience Required
Must have at least 3-5 years of related experience.
Education Requirements
Biology, Research, Public Health, Business Administration, Healthcare Administration or related field