Responsibilities:
Major responsibilities include
Review language in research related agreements and
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
Qualifications:
Paralegal Certification Preferred
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