- University of Pennsylvania (Philadelphia, PA)
- …reviews medical or research data for study eligibility; and helps prepare documentation for compliance and reporting. Contributes to reviews to the IRB, literature ... records. + Communicate with research partners to obtain required data and documentation ; support processing of study-related invoices or expenses. + Assist as needed… more
- University of Pennsylvania (Philadelphia, PA)
- …are conducted within protocol designated timeframes including documentation of lost-to-follow-up efforts. Schedule additional protocol-required tests/procedures. ... preparation and processing of all Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments and adverse event reporting.… more
- Quality Technology Services, LLC (PA)
- …schedule of values aligns with the contract, verify the required monthly documentation , reconcile the project budget as needed, and inform the project management ... legal department as necessary. + Support the finance team with the monthly loan draw process as required, including acquiring any necessary documentation from… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …support mitigation plans for supplier-related quality issues. + **Compliance & Documentation ** + Ensure supplier compliance with global regulatory requirements (eg, ... FDA, EMA, ICH). + Prepare documentation and support internal and external audits and inspections. + Maintain accurate records of supplier performance and audit… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …external experts and is accountable for ensuring all contracts, payments, and documentation are processed efficiently, compliantly, and in accordance with the CoE's ... issues to the Associate Director for strategic resolution + Maintain meticulous documentation and record-keeping for all HCP contracts and interactions to ensure the… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a ... DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation . Participates in regulatory inspections and audits as required. +… more
- University of Pennsylvania (Philadelphia, PA)
- …the development of consent forms, case report forms, checklists and other study documentation . Will mentor junior staff on good clinical practices in research. Job ... protocols, informed consent forms, case report forms and other related study documentation Conduct training of investigators, sponsors and clinical research staff in… more
- University of Pennsylvania (Philadelphia, PA)
- …Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review ... with minimal supervision, prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI… more
- University of Pennsylvania (Philadelphia, PA)
- …The role oversees day-to-day operations, financial transactions, and documentation compliance, supports proposal and reporting activities, and contributes ... aspect of this position involves coordinating compliance and research documentation requirements. The coordinator tracks and proactively communicates deadlines for… more
- University of Pennsylvania (Philadelphia, PA)
- …to a citywide GVRS evaluation effort by reinforcing reliable data routines, documentation of decisions and progress, and shared standards for implementation fidelity ... to the citywide GVRS evaluation by reinforcing reliable data routines, documentation , and shared standards for implementation fidelity, and by synthesizing insights… more