- 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
- University of Pennsylvania (Philadelphia, PA)
- …in research team meetings. Prepares and submits regulatory documents to the IRB . Additional duties include regular office duties (eg scanning and filing research ... in research team meetings. Prepares and submits regulatory documents to the IRB . Additional duties include regular office duties (eg scanning and filing research… more
- University of Pennsylvania (Philadelphia, PA)
- …with minimal supervision, prepare and process all regulatory documentation through the IRB , CTSRMC, FDA and all applicable regulatory review committees- ... work as part of a team, as well as independently; knowledge of IRB and human research protection regulations, including ICH GCP guidelines. The successful candidate… more
- 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 of ... with external partners and community organizations + Maintain regulatory compliance and IRB documentation + Draft figures and contribute to manuscript and grant… more
- WellSpan Health (York, PA)
- …for clinical research patients. **Essential Functions:** + Participates in the review of research protocols and assesses the appropriateness, feasibility and ... consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of patients enrolled in research studies.… more
- University of Pennsylvania (Philadelphia, PA)
- …The coordinator must be detail oriented and have prior experience with IRB guidelines and policies and human subject research practices and appropriate professional ... study protocols. In addition to the duties above, CRC Bs will manage IRB submissions and potentially help orient/train other CRCs. Position is contingent on… more
- Geisinger (Danville, PA)
- …+ Performs coverage analysis for clinical studies, including billing determination review and Medicare coverage analyses to ensure regulatory compliance. + Creates ... 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
- Carnegie Mellon University (Pittsburgh, PA)
- …administration functions and related systems (eg, proposal development, compliance, award management, IRB ) is highly desirable but not required. + A combination of ... education and relevant experience from which comparable knowledge is demonstrated may be considered. **Analytical Skills:** + Oral and Written Communication Skills + Problem-Solving and Reasoning Skills + System Analysis & Design Experience **Requirements:** +… more
- University of Pennsylvania (Philadelphia, PA)
- …or CRO, includes source documentation, case report forms, and research charts. Collect, review and report study data. Complete case report forms and resolve data ... and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start up activities....of a team, as well as independently; knowledge of IRB and human research protection regulations; high reliable and… more
- Highmark Health (Pittsburgh, PA)
- …OVERVIEW:** Manages research projects via study protocol, regulatory requirements and institutional policy; performs the nursing process for the study participants ... fulfilling requirements of the research protocol. (5%) + Ensures compliance with the IRB and all regulatory agencies. (5%) + This position may support activities… more