- Abbott (Alameda, CA)
- …Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and ... training of new study investigators and writing and assembling submissions. + Maintain and audit Trial Master File to ensure inspection readiness. + Perform review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical… more
- IQVIA (Los Angeles, CA)
- …available for filing in the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with GCP and local regulatory ... requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Collaborate and… more
- Merck (South San Francisco, CA)
- …definitive/Good Laboratory Practice (GLP)], serving as a contributing scientist/principal investigator on toxicity studies, and executing PK/TK strategies to support ... the development of small molecules and biologics. The successful candidate will collaborate on cross-functional teams to ensure analytical solutions and interpretations are appropriate to address program goals or capability gaps. They will interpret results in… more
- BeOne Medicines (San Mateo, CA)
- …aligned to commercial and regulatory objectives + Clinical trial patient and investigator recruitment and retention experience + Validated experience in project and ... budget management + Confirmed global working experience **Travel:** as needed All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or… more
- IQVIA (Carlsbad, CA)
- …are available for filing in the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with GCP / ICH and local ... regulatory requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Act as a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …amendment, and routine submissions (eg, Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.). + Oversees and approves the authoring of ... regulatory documents, including meeting requests, Module 1 documents for original IND, etc. + Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets. +… more
- University of Southern California (San Diego, CA)
- …AssociateApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/San-Diego-CA/Clinical-Research- Associate \_REQ20160224/apply) Keck School of Medicine San ... remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …regulatory strategy + Provide input/review of clinical documents, eg protocols, investigator 's brochures, case report forms + Participate in site/ investigator ... and presentations + Attend and provide medical support for investigator and consultant meetings and clinical advisory boards +...an equivalency could include 8 years of experience, an Associate 's degree with 6 years of experience, or a… more
- Amgen (Thousand Oaks, CA)
- …Let's change the world! Amgen is currently seeking a Sr. Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of Amgen's ... and to optimize the patient experience. The Sr. Complaints Technical Investigator conducts technical investigations, including root cause analysis, for complaints… more
- Cedars-Sinai (Beverly Hills, CA)
- …protocol knowledge to serve as a liaison between nursing staff, Principal Investigator , other research staff, and study participants. Assists with the education of ... to protocols and serves as a liaison between study participants, Principal Investigator (PI), and other research staff. + Provides educational services to research… more
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