AtCooper 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 our 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 DescriptionMajor responsibilities include
1) review language in research related agreements and
2) review and reconciliation of regulatory terms/issues in clinical trial agreements, IRB submissions, and informed consent forms.
Reviews research related agreements (e.g. confidential disclosure agreements, clinical trial agreements, and subawards) provided by sponsors and negotiates the terms/language to comply with CUHC requirements.
Reviews IRB submissions for funded studies and provides financial disclosure clearance for key study personnel and reconciles whether Legal or the Privacy Officer need to provide Material Transfer
Agreements and Data Use Agreements, and tracks that these get completed in a timely manner.
Responsible for educating investigators and tracking compliance with federal and Cooper policies regarding reporting and managing conflicts of interest
Coordinates, tracks, and delivers training pertaining to research related regulatory issues to researchers.
Maintains and updates research policies
Maintains CRI webpage
Works with Compliance to maintain public resource for requests for financial conflicts of interest of clinical trial key study personnel
Completes annual NJ EPA waste report for the E&R Building
Experience Required3-5 years of appropriate experience reviewing research contracts
Education RequirementsBachelor’s Degree and High School Diploma REQUIRED
License/Certification RequirementsParalegal Certification Preferred
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