Clinical Research Regulatory Affairs Associate
As the Clinical Research Regulatory Affairs Associate, you will be responsible for assisting the coordination of the clinical research components for investigational products under the purview of the Food and Drug Administration (FDA), Recombinant Advisory DNA Committee (RAC) and Office of Biotechnology Activities (OBA). We are an “all-in” type of culture and you will play a key role in keeping our standards high for clinical research activities. This type of work involves you gaining rapport and credibility with internal and external stakeholders. Responsibilities include the following:
- Assist study teams with creation and approval of drug/biologic/device applications for IND and IDE phase I and early phase 2 studies
- Collect data necessary for regulatory submissions
- Maintain the clinical trials regulatory compliance program to assure adherence to local, state and federal regulations, and institution policies and procedures for the responsible conduct of institutional clinical research activities.
- Track reportable events such as protocol violations/deviations, adverse event and serious adverse events
- Represent St. Jude as a point of contact to the external regulatory authorities for questions and issues regarding specific applications
- Coordinate with St. Jude research staff to improve the quality of applications
- Propose improvements to the regulatory application process
Acting as a liaison with FDA project managers, you communicate regularly and provide feedback to St. Jude study teams. You will have the opportunity to be on the cutting edge with experimental studies with direct principal investigator interaction. Take the first step to join our team by applying now!
- Bachelor’s degree in scientific, healthcare or related field required
- Three (3) of research and/or regulatory compliance experience in a scientific or healthcare related field required
- Experience with federal research compliance regulations (e.g., NIH, OHRP, FDA, CMS, USDA, OSHA and/or OBA) required
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Job posted: 2020-11-13