- Sumitomo Pharma (Santa Fe, NM)
- …and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop and ... of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory... study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with… more
- Edwards Lifesciences (Austin, TX)
- … clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory compliance + Experience working in a ... trial patients' safety by assuring trials are conducted ethically and within regulatory compliance , data accuracy, and protocol adherence. The ideal candidate… more
- Dialysis Clinic, Inc. (Nashville, TN)
- …providers. **The Laboratory Quality & Compliance Manager** oversees all quality management activities for the clinical laboratory including quality ... processes for clinical and environmental testing. The position also ensures compliance with local, state, and federal regulatory standards such as the … more
- Lilly (Indianapolis, IN)
- …study initiation and conduct (ie, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and ... Drug/ clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs) If experience is either in 2 and… more
- Omaha Children's Hospital (Omaha, NE)
- …management team with staff. * Ensures all logs and data are maintained in compliance with state regulatory agencies. * Maintains and ensures proper timekeeping ... other regulatory agency standards. * Prepares, maintains and monitors clinical staff schedule to assure appropriate coverage and avoid unnecessary overtime. *… more
- University of Utah (Salt Lake City, UT)
- …study teams, and clinical teams, the QA Specialist ensures regulatory compliance , operational efficiency, and consistently high standards of documentation ... BMT clinical research administrative programs** by monitoring and improving the quality and compliance of administrative clinical research operations.… more
- Dana-Farber Cancer Institute (Boston, MA)
- …scheduling, patient flow, access, revenue integrity, coding, and regulatory compliance . + Ensure data-enabled practice by aligning clinical , financial, and ... systems that recognize excellence, drive accountability, and support continuous professional growth. ** Regulatory Compliance and Quality Assurance:** + Build… more
- University of Colorado (Aurora, CO)
- …and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance , sponsor communication and post and pre ... study protocols + Train and onboard study personnel at other sites and ensure regulatory compliance + Communicate with study personnel at other sites, including… more
- Bassett Healthcare (Cooperstown, NY)
- …with direct accountability for clinical practice as it relates to, quality and regulatory compliance , interventional and procedural based activities. ... standards, quality metrics, and key performance indicators + Ensures compliance with all regulatory agency requirements (eg JCAHO/NYSDOH) and serves… more
- University of Utah (Salt Lake City, UT)
- …and four years of clinical research experience that includes regulatory compliance monitoring/auditing, IRB application submission, and experience in human ... in preparation for regulatory audits by developing, monitoring and updating quality controls and recommending actions to maintain compliance . This position… more