- Geisinger (Danville, PA)
- …and materials, as well as IRB meeting minutes. + Records convened Institutional Review Board discussion and stipulations, and ensures accurate ... for regulatory and compliance issues. Provides technical support for Institutional Review Board system users...Administers educational programs pertaining to human research protections and IRB review processes for IRB … more
- University of Pennsylvania (Philadelphia, PA)
- …maintain all regulatory clinical trial documents and protocols ensuring compliance with the Institutional Review Board , the Abramson Cancer Center Trial ... or other programs. + Preparing study reports, annual reviews, and Institutional Review Board documentation + Liaising with key stakeholders, including… more
- Actalent (Philadelphia, PA)
- …documents, informed consents, case report forms, and source documents. The preparation of Institutional Review Board ( IRB ) applications will also ... documents, informed consents, case report forms, and source documents. + Prepare Institutional Review Board ( IRB ) applications. Essential Skills +… 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 ... institutional or study related committees and personnel (eg, IRB , DSMC, DSMB/Medical Monitor) according to applicable regulations and...to all applicable PENN institutional committees for review and approval to start trial (eg, IRB… more
- University of Pennsylvania (Philadelphia, PA)
- …of multiple clinical research projects investigating surgical outcomes in the US Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... clinical research projects investigating surgical outcomes in the US Assist with Institutional Review Board ( IRB ) filings and inquiries, and assist… more
- University of Pennsylvania (Philadelphia, PA)
- …duties and responsibilities as assigned Regulatory Responsibilities: + Prepare and process all Institutional Review Board ( IRB ) documentation through the ... Initiation meetings + Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines. + Obtain records required to complete case report… 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 ... compliance is essential. This position requires adherence to University of Pennsylvania, IRB , and FDA guidelines, and may occasionally involve off-site work or… 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)
- …+ Ability to pre-screen patients effectively. + Knowledge of Good Clinical Practice (GCP), Institutional Review Board ( IRB ), and Electronic Data Capture ... (EDC) systems. Additional Skills & Qualifications + 1-2 years of related experience or an equivalent combination of education and experience. Work Environment This role offers flexibility with work-from-home options: the first week is on-site, with one day of… more
- University of Pennsylvania (Philadelphia, PA)
- …study initiation; maintaining study regulatory binders; submission of all regulatory paperwork to our institutional review board ( IRB ) and any applicable ... 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