- Prisma Health (Greenville, SC)
- …Health Research services, including the CRMO (Clinical Research Management office, IRB ( Institutional Review Board ) and OSP (Office of Sponsored ... protocol parameters. Assists MD investigator in the informed consent process. Provides coordination over assigned research staff. Ensures assigned study staff… more
- Johns Hopkins University (Washington, DC)
- …and advisor to the Director on priorities and resource allocation. Develop, submit, and maintain Institutional Review Board ( IRB ) and Data Use Agreement ... and Policy Modeling (CHSPM) is seeking a strategic, highly organized Sr. Program Manager to lead the coordination and execution of Center activities. Reporting… more
- Johns Hopkins University (Baltimore, MD)
- …of such forms. Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review regulatory accuracy and overall study ... Under the direct supervision of the GU Clinical Research Program Manager or the Principal...clinical studies which require a high level of knowledge, coordination , and data abstraction. Transmits and distributes protocol information.… more
- Johns Hopkins University (Baltimore, MD)
- Reporting to the Senior Division Manager , Nurse Manager and or the Lead Research Nurse, we are seeking a Sr Research Nurse who will be responsible for ... submits required regulatory documents. May participate in drug data sheet development/ review /revision. Monitors for IRB approval/request for further information… more
- WCG Clinical (Cary, NC)
- …CAPAs and Continuous Improvement. + Stay abreast of applicable federal regulations governing IRB review of research by attending seminars, training sessions, ... Manager , Client Success (Remote) **General Information** **Location:** Cary,...operations process flow from preparation of submission materials for board review through outcome documents being sent… more
- Johns Hopkins University (Baltimore, MD)
- …group/internal audits/monitoring. Assists with development & review of institutional SOPs pertaining to performance of clinical research . Maintains ... Nurse that will report to the Principal Investigator(s), Research Nurse Manager , and Lead Research...Research Nurse. This position is responsible for the coordination and implementation of assigned clinical trials within the… more
- 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
- Cedars-Sinai (Los Angeles, CA)
- …for long term follow-up patients only. + Assists with regulatory submissions to the Institutional Review Board ( IRB ) including submission of Adverse ... and Drug Administration (FDA) and local Institutional Review Board . + Maintains research ...- Assists supervising staff with regulatory submissions to the 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 ... protection + Other duties and responsibilities as assigned CRC-A + Prepare and process all Institutional Review Board ( IRB )through the IRB and… 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
- 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
- UPMC (Pittsburgh, PA)
- …clinical orientation, continuing education, and supports specialty certification. + Assists in institutional review board ( IRB ) document preparation ... of cancer. UPMC Hillman Cancer Center is currently hiring a regular full-time Clinical Research Manager to help support the Women's Oncology Clinical Research… 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
- University of Pennsylvania (Philadelphia, PA)
- … visits in clinic; maintaining regulatory files; and preparing submissions to the Penn Biomedical Institutional Review Board ( IRB ) and central IRBs when ... and implement strategies for participant recruitment. * Work closely with the Clinical Research Program Manager on study start-up activities. Job Description Job… 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
- 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
- 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
- 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
