- Sumitomo Pharma (Nashville, TN)
- …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
- Vanderbilt University Medical Center (Nashville, TN)
- …and archiving of study files, ensuring completeness and continuity of all study data , performing ongoing checks of clinical /translational data that has ... and/or senior personnel who will determine if a protocol amendment or other safety reporting to appropriate funding/ regulatory agencies is required. + Utilizes… more
- Vanderbilt University Medical Center (Nashville, TN)
- …and archiving of study files, ensuring completeness and continuity of all study data , performing ongoing checks of clinical /translational data that has ... Summary:** JOB SUMMARY In your pivotal role as a Clinical Research Coordinator 1, you will coordinate the approval...who will determine if a protocol amendment or other safety reporting to appropriate funding/ regulatory agencies is… more
- Bausch + Lomb (Nashville, TN)
- …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
- 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 ... our patients' needs. This position is for an experienced clinical trials coordinator with a work ethic dedicated to...problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects… more
- Vanderbilt University Medical Center (Nashville, TN)
- …past experiences, and new information to determine key opportunities. - Fulfills Safety and Regulatory Requirements: Develops appropriate corrective actions for ... with other departments. + Follow-up/expedite work on obtaining information on procedures, data , or analysis of problem situations in order to get things done.… more
- Otsuka America Pharmaceutical Inc. (Nashville, TN)
- …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
- Fresenius Medical Center (Knoxville, TN)
- …service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements. Ensure provision of quality patient care ... while maintaining cost-effective clinical operations in accordance... operations in accordance with all legal, compliance, and regulatory requirements and programs. Adheres to all requirements of… more
- Community Health Systems (Franklin, TN)
- …The EVP collaborates with internal and external stakeholders to enhance clinical outcomes, operational performance, regulatory compliance, and financial results ... strategic goals. **Essential Functions** + Provides executive oversight of key clinical services, ensuring alignment with organizational goals, regulatory … more
- ThermoFisher Scientific (Lebanon, TN)
- …of issues in consultation with the Global Medical Indication Lead + Interpret the clinical trial data for regulatory documents (eg CSR, INDs, Annual ... through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development...team, in order to provide reliable, high quality study data within time and budget. **A day in the… more
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