- Rush University Medical Center (Chicago, IL)
- …AE/SAE and deviation reporting. 11. Implements department-level process improvements in coordination with Research Manager ; identifies training gaps ... * Bachelor's degree **Experience:** * 3+ years of progressive clinical research coordination * Independent site management experience OR Experience… 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 ... protection + Other duties and responsibilities as assigned CRC-A + Prepare and process all Institutional Review Board ( IRB )through the IRB and… more
- Cedars-Sinai (Beverly Hills, CA)
- …federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board ( IRB ). **Primary Duties and ... and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board ( IRB ) to submit Adverse Events, Serious… more
- Stanford University (Stanford, CA)
- …compliance with all applicable institutional , regulatory, and federal requirements. Monitor Institutional Review Board ( IRB ) submissions and ... Clinical Research Lab Manager (Fixed-term 2 years)...or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and… more
- 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
- Stanford University (Stanford, CA)
- …bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. IRB submissions. + 2-4 years ... regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to… 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
- Dana-Farber Cancer Institute (Boston, MA)
- …identify priority trials and complete submissions through IRIS. Process protocols through DFCI Institutional Review Board (and other institutions' IRBs) + ... of clinical trials and assist the disease group's Clinical Research Manager in their resolution + Manage...continuing reviews, events, and other submissions for SRC and IRB review and approval + Support the… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board ( IRB ) policies and ... maintain all correspondence and regulatory documentation required by the IRB , FDA, IND Sponsors, and other institutional ...+ Process IND safety reports, maintain documentation of PI review and submit safety reports to the IRB… 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 Radiology CRG Clinical Research Manager , the Clinical Research ...applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are… more
- Johns Hopkins University (Baltimore, MD)
- …make recommendations on operational issues. + Assist with the preparation of submissions to the Institutional Review Board ( IRB ). + Liaison with IRB ... is seeking a **_Research Program Coordinator_** who reports to the Sr. Clinical Research Manager . Researchers at Johns Hopkins University conduct clinical trials… 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
- Veterans Affairs, Veterans Health Administration (Buffalo, NY)
- …resolved. Develops and maintains a pre- review program that will coincide with the IRB review of all research involving human subjects Develops and ... Summary This position serves as Health System Specialist - Research Committee Manager within the Research...requirements as they relate to human subject and the research review process. Initiates or reviews correspondence… more
- Mount Sinai Health System (New York, NY)
- …and proposals by developing pilot studies and generating pre-clinical data. + Completes all Institutional Review Board ( IRB ) or IACUC and other ... if no Masters degree) in data management and study coordination in healthcare or basic research . **Responsibilities**...techniques. + Provides assistance to the Principle Investigator or Research Manager on grant applications. + Assists… more
- University of Miami (Miami, FL)
- …review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . Project Manager , Research Support The University of ... Neurology has an exciting opportunity for a full-time Project Manager , Research Support to work in Miami,... Network. The successful candidate will have significant clinical research , proficiency with working through a central IRB… more
- Kennedy Krieger Institute (Baltimore, MD)
- …including collecting, analyzing, and archiving data. **Responsibilities** 1. Prepare and submit Institutional Review Board ( IRB ) required materials, ... activities including: participant recruitment and scheduling, study procedure scheduling and coordination , obtaining results and ensuring clinician review , and… more
- Loyola University Chicago (Chicago, IL)
- …for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. + Assemble ... complete study documents/case report forms. + Ensure compliance with research protocols, and review and audit case...+ Ensure essential documentation and recording of Patient and Research data in appropriate files per institutional … more
- Cedars-Sinai (Beverly Hills, CA)
- …Knowledge of GAAP rules helpful **Req ID** : 12570 **Working Title** : Clinical Research Manager , Research Operations **Department** : Cancer - SOCCI ... customers, Faculty and support of Medical Center goals and philosophies. The Manager , Research Operations assumes fiscal responsibility through preparation of… more
- Stanford University (Stanford, CA)
- Research and Program Manager , Project Unleaded **Doerr School of Sustainability, Stanford, California, United States** **New** Administration Post Date 3 days ... to develop and lead an exciting new program. The Research and Program Manager will initially take...research study designs, protocols, and compliance documentation (eg, IRB , data use agreements). + Proven ability to translate… more