- 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
- 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
- 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)
- …community events to increase public awareness. _Regulatory Compliance_ + Responsible for Institutional Review Board ( IRB ) submission, verification ... data collection and management, specimen collection, handling and processing, compliance with IRB regulations and communicating with team members on the status of… 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
- Johns Hopkins University (Baltimore, MD)
- …with study participants over the age of 18, department physicians and staff, Institutional Review Board and Office of Research Administration staff, ... Assists the principal investigator in preparing regulatory submissions required for IRB and sponsor review . + Prepares and submit annual continuing review … 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)
- …The sIRB Research Assistant will provide support for research projects managed by the JHM IRB , serving as the central IRB of record for TIC and non-TIC projects. ... and research personnel. **Specific Duties and Responsibilities** + Reports to the IRB navigators and program managers for large multisite clinical trials in managing… more