- University of Miami (Miami, FL)
- …a proven experience in managing regulatory documentation and submissions to entities such as the Institutional Review Board ( IRB ) and the Food and Drug ... Develops SOPs and templates with guidance from the PI/Clinical Research Manager . + Oversees and facilitates eligibility...initial study requests, annual reviews and modifications to the Institutional Review Board ( IRB… more
- Dialysis Clinic, Inc. (Albany, GA)
- …and post-study closure. They prepare documentation for submission for review by the Institutional Review Board ( IRB ), recruit and screen study ... including the collection, preparation, maintenance, and submission of numerous study documents: Institutional Review Board ( IRB ) applications, CV's,… 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 ... to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and… more
- Cleveland Clinic (Cleveland, OH)
- …case report forms and regulatory documents for the conduct of research required by Institutional Review Board ( IRB ), Sponsor and FDA. + Collect and ... interact with physicians and investigators, clinical trial sponsors, clinical research team members, regulatory bodies ( IRB and... manager plays a vital role in protocol review and site monitoring coordination . Experience in… more
- University of Pennsylvania (Philadelphia, PA)
- …duties and responsibilities as assigned Regulatory Responsibilities: + Prepare and process all Institutional Review Board ( IRB ) documentation through the ... and retrospective observational studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on… 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 ... employer in Philadelphia, is a world-renowned leader in education, research , and innovation. This historic, Ivy League school consistently...to all applicable PENN institutional committees for review and approval to start trial (eg, IRB… more
- Baystate Health (Springfield, MA)
- …creation; data entry; basic data analysis; literature reviews; compiling and submitting Institutional Review Board ( IRB ) applications including ... and possessing excellent organizational and critical thinking skills. Reporting to the Research Project Manager for Dr. Kimberley Geissler, the Senior … more
- University of Washington (Seattle, WA)
- …and scientific principles. + Familiarity with Good Clinical Practice (GCP) guidelines and Institutional Review Board ( IRB ) processes. + Knowledge ... of the Bjornstad program. Under the direction of the Research Manager , the RC will have minimal...and review and complete regulatory submissions to Institutional Review Boards and other regulatory and… more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... the cancer arena. Reporting to the Breast CRG Clinical Research Manager , the Clinical Research ...applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are… 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 ... to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and… more