- University of Rochester (Rochester, NY)
- …while collaborating with internal leaders and Principal Investigators. Ensures that CHeT is clinical trial "audit ready" and that there is full adherence to ... under the FDA and other regulatory agencies, the EU Clinical Trial Directives, and other regulations and...and New Drug Applications (NDAs). + Implements and oversees risk- based quality management strategies tailored to biopharma and medical… more
- University of Rochester (Rochester, NY)
- …capacity. **ESSENTIAL FUNCTIONS** + Directs the development and execution of clinical trial activities for multi-center industry sponsored trials, including ... + Oversees entire study team, internal and external, including clinical trial sites, clinical and...candidates, for all persons consistent with our values and based on applicable law. Notice: If you are a… more
- Naven Health (Syracuse, NY)
- …infusion services for a broad range of specialized therapies, as well as clinical trial services and special programs for pharmaceutical manufacturers. Joining ... our unyielding commitment, always.** Naven Health is a nationwide home infusion nursing network and clinical platform...plan of treatment in response to changing patient status based on physician orders to achieve established or revised… more
- University of Rochester (Rochester, NY)
- …emergency "disaster" situations. Assists technologists in the pre-analytical processing of clinical trial study specimens. + Communicates policies and ... development and review of requisitions. Makes suggestions to improve requisitions based on customer and staff feedback. Participates in regularly scheduled meetings… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical ... _This position can be based in Armonk, NY, Warren, NJ, Cambridge, Mass,...assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and… more
- University of Rochester (Rochester, NY)
- …ship operations (PNS) required to ship labeled product to site for use by clinical trial participants. This includes the first QA check only. Document ... QA liaison to external client inquiries regarding project related issues. + Follow-up with clinical trial sites in response to inquiries and resolve problems. +… more
- University of Rochester (Rochester, NY)
- …regulatory paperwork in accordance with human subject IRB, continuing education, clinical trial , and grant agency requirements and timelines. Demonstrates ... Board documentation preferred. + Experience with grant progress reports, clinical trial registration, and other regulatory processes...candidates, for all persons consistent with our values and based on applicable law. Notice: If you are a… more
- University of Rochester (Rochester, NY)
- …eligibility in clinical trials. + Conduct FDA-registration quality clinical trial visits, including, consenting, visit assessments, intervention ... liase with study monitors. + Participate in preparing investigator-inodiated clinical trial materials (eg, protocols, consent forms,...candidates, for all persons consistent with our values and based on applicable law. Notice: If you are a… more
- University of Rochester (Rochester, NY)
- …, and the Center for Translational Neuromedicine (https://www.urmc.rochester.edu/ctn.aspx) , to support clinical trial readiness activities to be at the cutting ... of the individual, and with consideration to related position salaries. Alignment of clinical incentive- based compensation may also be applicable and will be… more
- University of Rochester (Rochester, NY)
- …, and the Center for Translational Neuromedicine (https://www.urmc.rochester.edu/ctn.aspx) support clinical trial readiness activities to be at the ... of the individual, and with consideration to related position salaries. Alignment of clinical incentive- based compensation may also be applicable and will be… more
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