- Cedars-Sinai (Los Angeles, CA)
- …Operating Procedure development, etc. *May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or ... field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures,… more
- Parexel (Sacramento, CA)
- …the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance ... The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (eg… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Drug development experience, either within industry or as a clinical investigator /physician scientist in academia, or equivalent experience; drug development ... clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. + Ensures adherence to regulatory requirements of… more
- Cedars-Sinai (Beverly Hills, CA)
- …trial budgets for industry, National Institutes of Health (NIH), and investigator -initiated clinical research. Evaluates research protocols to assess resource needs, ... procedures, clinical research staff time, investigator time, and costs from ancillary departments. Determines cost...all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. **Primary… more
- IQVIA (Los Angeles, CA)
- …to clinical trial sites and review clinical practice topics as requested by the investigator or referring sites. + Act as the point of contact with thought leaders ... for investigator -initiated study (IST's) ideas within company pipeline assets. +...respective requirements of the customers are met. Reports of drug risks are sent in writing directly to the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical ... but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. + Manages the clinical development component(s) in the… more
- BeOne Medicines (Emeryville, CA)
- …development, update, and review of safety communication documents (eg, Dear Investigator Letter, Informed Consent Form, Investigator 's Brochure, Healthcare ... review of the Safety Management Plans. + Lead Safety Science specific investigator training. + Risk Assessment, Regulatory Inquiries, and Periodic Reporting. + Lead… more
- Gilead Sciences, Inc. (Foster City, CA)
- …including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data ... scientific and clinical leadership or oversight in the preparation of investigator brochures + Provide scientific and clinical leadership to cross-functional teams… more
- Cedars-Sinai (Los Angeles, CA)
- …program has been expanded to include Experimental Therapeutics (Phase I) and Drug Development programs. With this commitment strengthened, we can continue to make ... research protocol knowledge to serve as liaison between nursing staff, Principal Investigator , other research staff, and study participants. Serves as a resource and… more
- Cedars-Sinai (Los Angeles, CA)
- …compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). **Primary Duties and ... timely manner. Projects may include but are not limited to investigator -initiated protocol development including protocol writing, case report form development,… more