- Johns Hopkins University (Baltimore, MD)
- …serious adverse event reporting with the investigators to ensure prompt reporting to the IRB , DSMB, and study sponsor + Review protocol amendments to identify ... research, annual renewals, amendments, and adverse event reports to IRB , DSMB, and sponsor (as applicable). + Assist in...sponsor (as applicable). + Assist in the preparation of IRB , DSMB, and sponsor reports. + Provide timely data… more
- Johns Hopkins University (Baltimore, MD)
- …Principal Investigators on studies to ensure timely, accurate submission to the IRB of studies applications. + Assure study protocols have complete, consistent ... Obtain all required documents for study submissions to the IRB . + Track each protocol through the IRB...+ Maintain a continued high level of expertise in institutional databases including REDCap, OpenSpecimen, EPIC, Oncore, eIRB, using… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …with all stakeholders needed to execute a clinical research study including the FDA Institutional Review Board , FDA Human Subject Protection liaison, FDA ... external collaborators. + Develop study budget estimates. + Draft and/or review all required documentation: study protocol, informed consent form, statistical… more
- University of Maryland, Baltimore (Baltimore, MD)
- …protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents. Conducts quality assurance ... and all relevant local, federal, and state regulatory and institutional policies. Develops and prepares study or research related...Maryland license in good standing issued by the Maryland Board of Nursing to practice as a registered nurse… more
- Johns Hopkins University (Baltimore, MD)
- …by the JHU equivalency formula. **Preferred Qualifications** + Experience submitting Institutional Review Board Applications. + Experience conducting ... or coursework in quantitative analysis. + Data analysis using Stata or R. + Collaborative and with strong relationship-building skills. + Organized, efficient and detail oriented. + Able to handle multiple tasks and assignments. + Independent learner and… more
- Johns Hopkins University (Baltimore, MD)
- …ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB /ethics committee review /approvals, and assist with the collection of all ... regarding specified trial cycle metrics, protocol fidelity, and oversee local, institutional and federally required regulatory compliance across the network of… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …Provide human subjects protection regulatory and scientific support services via the review of research protocols submitted to the WRAIR, HSPB to include ... compliance with relevant regulatory requirements and draft a Protocol Evaluation Form (PEF)/pre- review for each action received. + Reviews and writes a variety of… more
- Johns Hopkins University (Baltimore, MD)
- …recruitment flyers, data collection sheets, consent forms, etc.). Edit and complete IRB submissions, including new projects, continuing review , change in ... (OnCore, REDCap, Openspecimen, iLabs). + Ensure adherence to study protocols ( IRB compliance) and study quality and maintain patient confidentiality. + Travel… more
- Johns Hopkins University (Baltimore, MD)
- …required regulatory documents. + May participate in drug data sheet development/ review /revision. + Monitors for IRB approval/request for further information ... of protocol and other manuals/documents to clinical CORES for review & input as appropriate. + Assures study documents...as appropriate. + Determines that IRB approval has been received and study status is… more
- Johns Hopkins University (Baltimore, MD)
- …to coordinating research activities with other teams including international partners, managing IRB and ACUC submissions, and gaining MTA and permit approvals for ... freezers. + Assist with research coordination including generating, filing and managing IRB and ACUC applications, as well as MTA permit applications required for… more