- 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
- Houston Methodist (Houston, TX)
- …Procedures (SOPs), and study specific protocols/plans and processes. The Sr Regulatory Compliance Specialist position maintains documentation for clinical ... in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and...Regulatory Affairs Certifications (RAPS) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified … 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 (Austin, 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
- 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
- Houston Methodist (Houston, TX)
- …resolves queries. Ensures accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing. + Assists ... of Clinical Trial Manager which may include clinical research protocols, gathering patient data via...the study protocol, study reports. This position ensures accurate data collection, documentation organization, and safety of… more
- Houston Methodist (Houston, TX)
- …a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/ regulatory required safety ... At Houston Methodist, the Manager Clinical Trials position is responsible for managing complex research projects that may involve single or multiple sites and/or… more