- Geisinger (Danville, PA)
- …procedural guidance for regulatory and compliance issues. Provides technical support for Institutional Review Board system users and serve as a liaison ... with regulatory requirements, institutional and Institutional Review Board policies and...as IRB meeting minutes. + Records convened Institutional Review Board discussion and… more
- Actalent (Philadelphia, PA)
- … documents, informed consents, case report forms, and source documents. The preparation of Institutional Review Board ( IRB ) applications will also be ... during the trials. + Collect study documents, including protocols, regulatory documents, informed consents, case report forms, and source...consents, case report forms, and source documents. + Prepare Institutional Review Board ( IRB… more
- University of Pennsylvania (Philadelphia, PA)
- …biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... coordination of study activities, including subject recruitment, data collection, regulatory documentation, and communication with internal and external collaborators.… more
- University of Pennsylvania (Philadelphia, PA)
- …and responsibilities as assigned Regulatory Responsibilities: + Prepare and process all Institutional Review Board ( IRB ) documentation through the ... deviation memos, physicians and coordinators' CVs and medical licenses, record of IRB certification and compliance). + Resolve regulatory related queries with… more
- University of Pennsylvania (Philadelphia, PA)
- …biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... doc.(eg, visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), enrollment log for...to all applicable PENN institutional committees for review and approval to start trial (eg, IRB… more
- University of Pennsylvania (Philadelphia, PA)
- …documentation through the IRB , CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, ... resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title...of a team, as well as independently; knowledge of IRB and human research protection regulations, including ICH GCP… more
- University of Pennsylvania (Philadelphia, PA)
- …biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... team members in retrieval and provision of documentation required for IRB submission/renewals in accordance with guidelines; continuing review , modification,… more
- University of Pennsylvania (Philadelphia, PA)
- …Description Prepare and process all Institutional Review Board ( IRB )through the IRB and other regulatory groups as appropriate including initial ... required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders) . Assist in the coordination of Phase I-IV… more
- University of Pennsylvania (Philadelphia, PA)
- … regulatory clinical trial documents and protocols ensuring compliance with the Institutional Review Board , the Abramson Cancer Center Trial Management ... other programs. + Preparing study reports, annual reviews, and Institutional Review Board documentation +...support from the PI, the coordinator will maintain all regulatory clinical trial documents and protocols ensuring compliance with… more
- University of Pennsylvania (Philadelphia, PA)
- …study regulatory binders; submission of all regulatory paperwork to our institutional review board ( IRB ) and any applicable central IRBs; ... the Division's overall research mission. Prepare draft PS-IDE applications for faculty review and submission to FDA. Draft components of clinical protocols and… more
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