- Guthrie (Sayre, PA)
- …investigational drug and device clinical trials + Oversight of investigator -initiated research. Determine feasibility, scientific review, funding and resource ... device exemptions (IDE), providing scientific expertise to the lead investigator . + Lead initiatives in research data governance, REDCap implementation,… more
- University of Pennsylvania (Philadelphia, PA)
- …and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with regulatory ... adverse events and ensuring review and appropriate follow-up by investigator , monitoring patient care and treatment side effects in...based on external market data for the job's level. Internal organization and peer data at Penn are also… more
- University of Pennsylvania (Philadelphia, PA)
- …proposals, and research related presentations. Works closely with the Principal Investigator , manager, and study team to identify problems and develop solutions. ... needed and monitor results. Responsible for project coordination for investigator -initiated studies, multi-center research studies, and patient-oriented clinical and… more
- University of Pennsylvania (Philadelphia, PA)
- …wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities. Research ... of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying...may take a lead role in study communication with internal and external groups. Work directly with investigators to… more
- Sumitomo Pharma (Harrisburg, PA)
- …regulations. + Participates/contributes to other activities such as literature evaluation, investigator site training, continuing education for internal staff, ... Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider… more
- University of Pennsylvania (Philadelphia, PA)
- …from observational trials to investigational product trials, including both investigator -initiated and industry-initiated trials. Work requires on-site presence and ... from observational trials to investigational product trials, including both investigator -initiated and industry-initiated trials. Work requires on-site presence and… more
- University of Pennsylvania (Philadelphia, PA)
- …and translational research studies led by the Susztaklab, including multi-site investigator -initiated projects such as Trident, PGDD, and KRAD. The role involves ... subject recruitment, data collection, regulatory documentation, and communication with internal and external collaborators. The individual will work closely with… more
- Bausch + Lomb (Harrisburg, PA)
- …and selection of investigators/sites. + Ongoing assessment, evaluation and management of internal and external resources. + Ensure study supply requirements are met. ... updates on progress and changes in scope, schedule, and resources. + Organize investigator and expert meetings relevant to the indication and assist with the… more
- University of Pennsylvania (Philadelphia, PA)
- …is seeking a part-time Project Manager to oversee both NIH-funded investigator -driven and industry-funded clinical trial research. The candidate will be directly ... manual of procedures. The Project Manager will also build relationships with internal and external project partners. The position requires managing quality assurance… more
- Sumitomo Pharma (Harrisburg, PA)
- …data collection of assigned clinical trials + Assists with preparation of potential investigator site lists and assists with their evaluation for inclusion in the ... as required + Participates in meetings - ie Study Team Meetings, Investigator Meetings, Monitors' workshops and CRO Training + Prepares and delivers program/study… more
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