- Actalent (Philadelphia, PA)
- …+ Ability to pre-screen patients effectively. + Knowledge of Good Clinical Practice (GCP), Institutional Review Board ( IRB ), and Electronic Data Capture ... (EDC) systems. Additional Skills & Qualifications + 1-2 years of related experience or an equivalent combination of education and experience. Work Environment This role offers flexibility with work-from-home options: the first week is on-site, with one day of… more
- System One (Pittsburgh, PA)
- …with study participants and potential community recruits. + Assists with and adheres to Institutional Review Board ( IRB ) renewal, modification, and ... approved protocols. + Recruits research subjects and conducts interviews and research assessments. Requirements: + Minimum Education Requirement: Bachelor's Degree + Experience Requirement: At least 3-5 years of clinical trial/clinical research experience… more
- University of Pennsylvania (Philadelphia, PA)
- …study initiation; maintaining study regulatory binders; submission of all regulatory paperwork to our institutional review board ( IRB ) and any applicable ... the Division's overall research mission. Prepare draft PS-IDE applications for faculty review and submission to FDA. Draft components of clinical protocols and… more
- University of Pennsylvania (Philadelphia, PA)
- …biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator. + Prepare detailed documentation of… more
- System One (Pittsburgh, PA)
- …and monitoring patients for complications and outcomes. + Assists with and adheres to Institutional Review Board ( IRB ) renewal, modification, and ... approved protocols. Recruits research subjects and conducts interviews and research assessments. Requirements: + Minimum Education Requirement: Bachelor's Degree + Experience Requirement: at least a year of direct clinical research/clinical trial experience is… more
- Guthrie (Sayre, PA)
- …Ensure IRB operations align with federal (OHRP, FDA), state laws and institutional policies. Provides guidance to the IRB in developing policies and ... procedures, interpreting regulations, obtaining Foundation Board approval of new IRB members, and...to safeguard ethical research conduct. 2. Research Governance & Institutional Integration + Serve as the Director of Research… more
- University of Pennsylvania (Philadelphia, PA)
- …with partnering institutions on creating multi-center budgets, managing invoicing, and IRB paperwork under limited supervision and will need to use independent ... adhere to all PENN, ICF, and FDA guidelines; prepare and process all IRB documentation. The clinical research coordinator B will also manage clinical trials that… more
- Guthrie (Sayre, PA)
- …Responsibilities for program development include assisting with feasibility, site selection, IRB document review , and corresponding with investigators, IRB ... sponsor. Guthrie's updates include patient protocol enrollments, document submissions to IRB , and event management of patient follow-up visits. Submit research data… more
- University of Pennsylvania (Philadelphia, PA)
- …information* Assisting or leading in the preparation and submission of IRB documents Coordinator A: Assist in the coordination of federally funded ... participants. Additional duties include assisting in preparation and submission of IRB documents, scheduling and conducting study visits per protocol, assisting with… more
- University of Pennsylvania (Philadelphia, PA)
- …and exams, as well as submitting modifications and continuing reviews to the IRB . The position involves abstracting information from medical records and data entry. ... screen, recruit and retain potential study participants. + Assist with IRB communications, including initial submissions, modifications. + Collect and report timely,… more