- 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
- 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 ... a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety...AEs, SAEs, and UADEs reports to the Investigator and Institutional Review Board ( IRB… 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
- Actalent (Philadelphia, PA)
- …informed consents, case report forms, and source documents. + Prepare applications for the Institutional Review Board ( IRB ). Essential Skills + ... involves coordinating clinical trials, managing patient recruitment, and ensuring regulatory compliance in a fast-paced environment. Responsibilities + Recruit,… more
- University of Pennsylvania (Philadelphia, PA)
- …Description Prepare and process all Institutional Review Board ( IRB )through the IRB and other regulatory groups as apropriate 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
- Actalent (Philadelphia, PA)
- …informed consents, case report forms, and source documents. + Prepare applications for the Institutional Review Board ( IRB ). Essential Skills + ... + Demonstrated teamwork and independent working capabilities. + Knowledge of IRB and human research protection regulations. + Strong computer skills, particularly… more
- Carnegie Mellon University (Pittsburgh, PA)
- …the Vice President for Research. The AVP will lead the offices administering CMU's Institutional Review Boards ( IRB ), Animal Care and Use Committee (IACUC), ... service-oriented manner. **_Core responsibilities include:_** + Provides strategic oversight of CMU's Institutional Review Boards ( IRB ), Animal Care and Use… more