- Houston Methodist (Houston, TX)
- …Director to ensure timely communication regarding status of regulatory and/or important safety related issues. + Perform high quality clinical review of ... Operating Procedures (SOPs), and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical … more
- Veterans Affairs, Veterans Health Administration (Dallas, TX)
- …and influence clinical and management decisions. b. Expert understanding of regulatory and quality standards for their program area. c. Ability to solve ... of the Position is: To serve as the Patient Safety Specialist who is organizational responsible to the Patient...support to the VA North Texas Health Care System clinical staff and appropriate clinical committees. Responsibilities… more
- Sumitomo Pharma (Austin, TX)
- …of emerging clinical trends and scientific advancements within Oncology. + Interpret clinical data , evaluate safety and efficacy, and make informed ... create scientifically rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality, patient safety ,...teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies… more
- Edwards Lifesciences (Dallas, TX)
- …clinical trial/study safety , in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Develop and deliver technical ... how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations… more
- Bausch + Lomb (Austin, TX)
- …clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management. + ... departments (eg, R&D/Project Management, Clinical /Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/Device Safety… more
- Houston Methodist (Houston, TX)
- …responsive interface among various departments and facilities as it pertains to patient safety , education, nurse triage and clinical quality. The Manager, ... At Houston Methodist, the Manager Clinical Operations position is responsible for providing ...and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/ regulatory required… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …them into clinical development plans to support drug development and regulatory packages **.** + Lead ** clinical pharmacology** activities related to study ... design, protocol development, study execution, data interpretation and study reporting.Conduct or oversee **PK and...and presented. Author PK reports that are integrated into clinical and regulatory documents. + Lead development… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards. + Mentors junior team members. ... to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The...potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct… more
- ICON Clinical Research (San Antonio, TX)
- … clinical research activities in accordance with study protocols, regulatory guidelines, and standard operating procedures (SOPs). + Conducting patient ... effectively with healthcare professionals and study investigators. + KNwledge of regulatory requirements governing clinical research, including the International… more
- Houston Methodist (Houston, TX)
- …to develop, coordinate, implement and evaluate activities associated with all phases of clinical research projects. Monitors safety of all research subjects and ... score for patient satisfaction, through peer-to-peer accountability to service standards. **QUALITY/ SAFETY ESSENTIAL FUNCTIONS** + Follows the clinical research… more
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