- University of Miami (Miami, FL)
- … regulatory bodies. Knows the contents and maintenance of study-specific clinical research regulatory binders. Maintains requisite skills and mandatory ... data quality control. Record serious adverse events, etc. in compliance with applicable regulations and report to IRB/Sponsor. Actively participates in… more
- J&J Family of Companies (Titusville, NJ)
- …legal, quality assurance, quality monitoring & compliance , clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, ... protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix… more
- Sharp HealthCare (Chula Vista, CA)
- …effective use of skill sets and workload through adequate scheduling.Maintain high quality patient care with clinical expertise and improved nutrition knowledge ... certification, and other mandatory training within established timeframes.Assists in achieving compliance with regulatory agency standards, including state and… more
- Penn Medicine (Philadelphia, PA)
- …collaboratively with the Practice Manager to ensure compliance with Regulatory , Infection Control, Human Resource, Quality and Safety, Patient Satisfaction ... assessing the clinical care team to ensure quality , compliance with governmental agencies and patient... projects. Participates in strategic and operational planning. Maintains regulatory compliance (TJC, CMS, DOH, OSHA) Maintains… more
- University of Miami (Miami, FL)
- …University‐wide policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best ... operations of study coordinator service lines for CTRS/ MSOM investigators, encompassing regulatory and study management services for clinical research trials. +… more
- University of Utah (Salt Lake City, UT)
- … Clinical Practices, FDA , HIPPA ICH , and IRB regulations and regulatory compliance . + Must be a self-starter with exceptional organizational skills, ability ... documents related to the study protocol. 2. Oversees compliance to protocol; manages quality control, completion...Good Clinical Practices ( GCP ), and clinical research standard operating procedures to ensure compliance… more
- J&J Family of Companies (Titusville, NJ)
- …TA strategy, global regulatory affairs, finance, legal, quality assurance, quality monitoring & compliance , clinical supplies unit, data management, ... life-cycle management, geographic expansion, and post-marketing commitments), protocol development, quality execution of clinical studies, preparation and… more
- Vanderbilt University Medical Center (Nashville, TN)
- …good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents ... budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance , providing reports investigators, department… more
- AbbVie (Irvine, CA)
- …experience in the pharmaceutical industry, academia, or equivalent. + Knowledge of clinical trial methodology, regulatory and compliance requirements in ... Participate and lead cross-functional teams to generate, deliver and interpret high quality research and clinical data supporting aesthetic indications and… more
- AbbVie (North Chicago, IL)
- …to support a global scientific and business strategy. + Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing ... programs. May lead cross-functional teams to generate, deliver, and disseminate high- quality clinical data supporting overall product scientific and business… more