- University of Pennsylvania (Philadelphia, PA)
- …day-to-day study operations including maintaining study databases, compliance with all IRB and regulatory documentation, and assisting with the preparation ... relationships and collaborate with external partners and community organizations + Maintain regulatory compliance and IRB documentation + Draft figures and… more
- University of Pennsylvania (Philadelphia, PA)
- …Research Project Manager in submitting documents to regulatory authorities (eg IRB , FDA, etc.) and/or review /monitoring boards (ie, DSMB, independent safety ... more. This individual will also be responsible for ensuring compliance with all IRB , sponsor, and institutional regulations and guidelines. There will be… more
- University of Pennsylvania (Philadelphia, PA)
- …visits, attends and participates in research team meetings. Prepares and submits regulatory documents to the IRB . Additional duties include regular office ... and participates in research team meetings. Prepares and submits regulatory documents to the IRB . Additional duties...Prepares and submits regulatory documents to the IRB . Additional duties include regular office duties (eg scanning… more
- University of Pennsylvania (Philadelphia, PA)
- …Summary The Clinical Research Coordinator is responsible for oversight, execution, and regulatory compliance of human subject research carried out in the Stroke ... including patient recruitment, data collection and management, and potentially some regulatory responsibilities. The coordinator must be detail oriented and have… more
- University of Pennsylvania (Philadelphia, PA)
- …protocols; scheduling and conducting research visits; and submitting to both Penn and central Institutional Review Boards ( IRB ). This person will work in a ... Transport specimens to multiple labs on campus. Prepare and submit IRB documentation including initial submissions, continuing reviews, amendments, and adverse event… more
- WellSpan Health (York, PA)
- …for clinical research patients. **Essential Functions:** + Participates in the review of research protocols and assesses the appropriateness, feasibility and ... and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding… more
- Geisinger (Danville, PA)
- …+ Performs coverage analysis for clinical studies, including billing determination review and Medicare coverage analyses to ensure regulatory compliance. ... between contracts, budgets, billing documents, and informed consent forms prior to full IRB approval to ensure all documentation is accurate and consistent prior to… more
- University of Pennsylvania (Philadelphia, PA)
- … regulatory documentation through the IRB , FDA and all applicable institutional regulatory review committees. In collaboration with clinical research ... Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision ,… more
- University of Pennsylvania (Philadelphia, PA)
- …and trackers, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start up activities. The CRC ... coordinator work includes study implementation, community outreach, document development, regulatory work, subject recruitment and enrollment, study visits and … more
- Bausch + Lomb (Harrisburg, PA)
- …the timely coordination and execution of clinical study reports. + Assist in the review of regulatory reports to ensure that reports accurately reflect proper ... evaluation, and selection of CROs and vendors (eg, central labs, central IRB , IVRS, etc.). + Manage the identification, evaluation, and selection of… more