- Johns Hopkins University (Baltimore, MD)
- …annual renewal requests, protocol amendments, and adverse event reports to institutional entities and sponsors. + Maintains regulatory binders for each assigned ... shipping per study protocol. + Meets regularly with study team leadership to review data accuracy and overall study progress. + Participates in all mandatory… more
- Johns Hopkins University (Baltimore, MD)
- …as applicable. + Assess human subjects research projects submitted to JHU's Homewood Institutional Research Board ( IRB ) that utilize student data for ... records teams and their leadership, Information Technology, General Counsel, Institutional Risk Management, and other partners; review /validate university-wide… more
- Johns Hopkins University (Baltimore, MD)
- …+ Provide research support including data cleaning, qualitative data collection, IRB management, and managing participant recruitment and renumeration. + Maintain an ... up-to-date tracker to monitor the status of evaluation projects. + Coordinate and lead evaluation team meetings, including drafting meeting agendas, capturing meeting minutes, and ensuring follow-up items are addressed. + Attend meetings with partners within… more
- Johns Hopkins University (Baltimore, MD)
- …requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements. + Adheres to all protocol requirements to ensure ... with the Principal Investigator, Research Nurse, and Research Nurse Manager to review data accuracy and overall study progress. + Participates in all mandatory… more
- Bausch + Lomb (Annapolis, MD)
- …evaluation, and selection of CROs and vendors (eg, central labs, central IRB , IVRS, etc.). + Manage the identification, evaluation, and selection of ... with the organization and management of DSMBs and Data Review Committees, as necessary. + Prepare study timelines and...to the IRBs/REBs/ECs. + Liaise with Data Management to review data discrepancies and ensure that data clarification forms… more