- J&J Family of Companies (Irvine, CA)
- …medical and technical documentation including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature ... Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Updates Report (PSUR) documents,...with the EU MDR regulations as it pertains to clinical evaluations, data sufficiency requirements, and state… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …and core clinical materials; monitor safety and participate in safety review /DSMB activities in EDO as needed. + Ensure CNS TM team robustly represents ... Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), Data & Analytics, Early Commercial, Medical… more
- University of Washington (Seattle, WA)
- …Program Directors and is integral to the department's mission in education, clinical training, and academic excellence. Our department specializes in the management ... programs and outstanding research programs, including both bench research and clinical trials, characterize the department. More than 400 full-time clinical… more
- Kelly Services (Austin, TX)
- **Senior Medical Director (Principal Investigator)** **Kelly(R) Science & Clinical ** is seeking an experienced Senior Medical Director (PI) for a direct hire ... dose escalation vaccine trials, phase II, III and IV clinical studies, in addition to diagnostic and device studies....trials as per GCP/HSP guidelines to ensure participant safety, data integrity, and responsibility for study staff. + Collaborate… more
- Cedars-Sinai (Los Angeles, CA)
- …Nurse Coordinator III is responsible for all activities associated with clinical study coordination, subject enrollment, data management/integrity, regulatory ... all of our patients with cancer. As part of this commitment, our cancer clinical trials program has been expanded to include Experimental Therapeutics (Phase I) and… more
- University of Kansas (Lawrence, KS)
- …Project Management, and Administrative Support:** + Train undergraduate students on data entry, lab policies, and procedures; provide oversight of undergraduate and ... onboarding of undergraduate research assistants and other CARE-related positions. **30% Data Reporting, Management, and Statistical Analysis:** + Run weekly and… more
- Genentech (Boston, MA)
- …to: exploratory analyses, application development and dynamic visualization to enable ongoing data review and scientific insights generation. The Analytical ... and align statistical programming practices across both early- and late-stage clinical development. **The Opportunity** The Analytical Data Science Program… more
- Beth Israel Lahey Health (Exeter, NH)
- …(eg Patient Safety Commitee). Facilitates intensive review of significant clinical adverse events. Analyzes data utilizing informal and formal analytical ... but not limited to, quality and safety event reporting and investigation, clinical performance improvement, quality and safety data management, support of… more
- University of Miami (Miami, FL)
- …and research support. 1. Enrolling new patients to participate in clinical research.2. Performs chart review /pre-screening activities for study participant ... enrollment procedures according to the protocol.3. Coordinates routine activities of clinical studies including data collection and maintenance, planning study… more
- University of Southern California (Los Angeles, CA)
- …years Preferred Skills: Staff education and orientation experience. Knowledge of Electronic Data Capture (EDC) systems and Clinical Trial Management Systems ... investigator-initiated research studies and D&I program including subject recruitment, data collection, scheduling of study-related activities and follow-up of… more