- Johns Hopkins University (Baltimore, MD)
- …+ Coordinate adverse event reporting with the investigators and ensure prompt reporting to the Institutional Review Board ( IRB ). + Adhere to guidelines ... each study participant is obtained using the most current IRB -approved consent forms; ensure that the original written consent...participant. + Meet regularly with the research team for review of data accuracy and overall progress; report on… more
- University of Maryland, Baltimore (Baltimore, MD)
- …position significantly contributes to the conduct of research. * Coordinates the preparation of Institutional Review Board ( IRB ) and Health Insurance ... * Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product...duties such as: monitoring the budget; budget negotiation and review , ensuring quality control and safety compliance; serving as… more
- Johns Hopkins University (Baltimore, MD)
- …ensure proper reporting to study sponsors and regulatory bodies. + Prepare and submit Institutional Review Board ( IRB ) applications, amendments, and ... are conducted per protocol, GCP (Good Clinical Practice), and institutional guidelines. + Screen and recruit eligible study participants...+ Conduct the informed consent process in compliance with IRB and federal regulations. + Review and… more
- Guidehouse (Bethesda, MD)
- …+ Track and review adverse event files and prepare reports in accordance with Institutional Review Board ( IRB ) processes and policies. + Prepare and ... safety reports, annual reports and correspondence. + Coordinate with IRB administrator to collect, review and maintain all IRB records. + Manage,… more
- Kennedy Krieger Institute (Baltimore, MD)
- …This position will additionally assist with manuscript preparation, grant support, and Institutional Review Board ( IRB ) submissions. **Responsibilities** ... all data records are stored according to HIPAA and IRB requirements. 5. Prepare and submit materials for ...IRB requirements. 5. Prepare and submit materials for IRB applications and renewals. **Qualifications** EDUCATION: * Bachelor's degree… more
- Kennedy Krieger Institute (Baltimore, MD)
- …those with neurological and psychiatric disorders. **Responsibilities** 1. Assist with preparation of Institutional Review Board ( IRB ) required materials ... events, etc.) and preparation of compliance and regulatory documentation for local (eg, IRB ), state, and federal (eg, Food and Drug Administration) agencies as well… more
- Johns Hopkins University (Baltimore, MD)
- …and make recommendations on operational issues. + Assist with preparation of submissions to the Institutional Review Board ( IRB ) + Liaison with IRB ... on administrative matters and facilitate communications with the PI(s). + Track/maintain regulatory documentation and clinical care documentation provided to increase regulatory compliance. + Serve as a resource for clinicians involved in the study regarding… more
- Kennedy Krieger Institute (Baltimore, MD)
- …a variety of diagnostic and cognitive assessment instruments adhering to study protocols and Institutional Review Board ( IRB ) requirements. 3. Assist ... and maintain participant records, ensuring accessibility, completion, and compliance with IRB standards. 6. Enhance professional growth and development through case… more
- Kennedy Krieger Institute (Baltimore, MD)
- …bibliography and reference pages, and editing and formatting documents. 14. Assist with Institutional Review Board ( IRB ) applications and renewals, ... as necessary, ensuring adherence to all applicable deadlines and requirements. **Qualifications** EDUCATION: * High School Diploma or GED required. * Bachelor's degree preferred. EXPERIENCE: Minimum two years of related program coordination experience… more
- 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