- Cedars-Sinai (Los Angeles, CA)
- …and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board . **Key Responsibilities:** + Coordinates data for ... guiding and training the next generation of clinicians. Our board -certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists… more
- Stanford University (Stanford, CA)
- …and submit application for approvals for research projects under supervision. + Draft regulatory and project reports. + Review and audit case reports to ... materials (eg recruitment materials, updated surveys) and submit to IRB to maintain IRB approval status of...involving human subjects. + Prior experience in developing literature review or research reports (coursework is fine). + Professional… more
- Actalent (Modesto, CA)
- …position at the site, working alongside a nurse lead. Responsibilities + Perform regulatory tasks, including IRB submissions. + Engage in sponsor correspondence, ... + Clinical trial management + Good Clinical Practice (GCP) + IRB knowledge + Regulatory experience + Patient recruitment + Data entry proficiency + Electronic… more
- Cedars-Sinai (Beverly Hills, CA)
- …objectives. + May manage the research study intake process, including feasibility, review and endorsement and PRMC submission, as well as capturing all trials ... compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements. Maintains staff and program… more
- Bausch + Lomb (Sacramento, CA)
- …the timely coordination and execution of clinical study reports. + Assist in the review of regulatory reports to ensure that reports accurately reflect proper ... evaluation, and selection of CROs and vendors (eg, central labs, central IRB , IVRS, etc.). + Manage the identification, evaluation, and selection of… more
- J&J Family of Companies (Irvine, CA)
- …independently; creating reports intended for internal distribution and for regulatory submission; creating internal presentations and white papers; and interfacing ... 1 and 2 job descriptions. + Interact with Biostatistics, Data Management, Regulatory , and Clinical staff to define and clarify project requirements. + Design… more
- Terumo Neuro (Aliso Viejo, CA)
- …the medical device industry to contribute to overall quality and regulatory compliance objectives. Encompass a broad spectrum of responsibilities including ... site, vendor, process, function, and systems); preparing for and hosting external regulatory inspections (eg, mock BIMO, BIMO, for cause, etc.); and planning,… more
- University of Southern California (San Diego, CA)
- …and study closeout visits are conducted in accordance within relevant regulatory regulations. + Monitors and manages ongoing documentation, regulatory , ... within clinical trials + In-depth knowledge of Good Clinical Practices (GCP), ICH, IRB , FDA, & HIPAA guidelines + Experience leading successful teams + Ability to… more
- Stanford Health Care (Palo Alto, CA)
- …initiation visits. + Supports practices relating to pharmacy dispensing based on IRB approved clinical trials. + Provides guidance to investigational drug service ... + Participates in audits from the sponsors, FDA, DEA, NIH and other regulatory agencies as needed. **Education Qualifications** + Bachelor's in Pharmacy from an… more
- Cedars-Sinai (Beverly Hills, CA)
- …clinical study coordination, subject Screening/recruitment/enrollment, data management/integrity, regulatory compliance, project/study evaluation and interfaces with ... department process (grade, attribution, treatment, etc), and reports to regulatory and sponsor as required. + Records research data...required and ensures protocol is followed. + May prepare IRB submissions. + May process, ship, track or otherwise… more