- Cedars-Sinai (Los Angeles, CA)
- …+ Coordinates grant activities pre award through closure (monitoring budgets, compliance , progress reports). + Identifies process improvement areas to assure an ... and preparation of clinical research policies and standard operating procedures. + Ensures compliance with all federal and local agencies including the Food and Drug… more
- Fujifilm (Sacramento, CA)
- …mapping for project and or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare ... customization, and electronic delivery of technical clinical tools and supplements. + Compliance with respect to all applicable requirements of the company's quality… more
- CSL Plasma (Stockton, CA)
- …+ In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates vein ... (SOPs). You will report to the Assistant Center Manager **The Role** + In compliance with SOPs perform all aspects of the pheresis procedure and plasma collection,… more
- University of Southern California (San Diego, CA)
- …study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance . + Act as main point of contact for assigned clinical sites. + ... manuals. + Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues. + Participate in monitoring activities to achieve study milestones. +… more
- Sharp HealthCare (San Diego, CA)
- …and procedures to facilitate application of SHC corporate commitment to compliance guidelines.Acts as Technical Consultant regarding abnormal or unusual orders or ... through, and prevention.Assists in maintaining CAP, JCAHO, CA state, AABB, FDA , and other accreditation and regulatory agency standards and regulations.Demonstrates… more
- CSL Plasma (Sacramento, CA)
- …* In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. * Evaluates vein ... the pheresis process and following Standard Operating Procedures (SOPs). * In compliance with SOPs, performs all aspects of the pheresis procedure and plasma… more
- J&J Family of Companies (Santa Clara, CA)
- …on cybersecurity and AI/ML requirements, oversee implementation, and ensure compliance . + Drive root cause analysis and corrective/preventive actions (CAPA) ... problem solving, and analytical skills + Working knowledge of IEC 62304, FDA 's General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR… more
- Merck (Sacramento, CA)
- …management, communication, and networking skills + A thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents… more
- Abbott (Alameda, CA)
- …+ Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, ... Protocols and Reports). + May interact with RA/QA in responding to audits and FDA inquiries. **Education and Experience** + BS degree in life sciences or equivalent… more
- Hologic (Los Angeles, CA)
- …Awareness of hospital purchasing processes, reimbursement models, and industry regulations ( FDA , HIPAA, Sunshine Act). + In-depth familiarity with the Sonata(R) and ... with internal teams to deliver comprehensive solutions. + Maintains integrity and compliance in all business activities. + Handles challenges with a positive… more