- Insmed Incorporated (San Diego, CA)
- …lock processesParticipate in activities related to data review , database lock, medical monitoring , and query resolution for the protocol and work with other ... related to the protocol (s) and program Provide protocol level scientific review of information to...systems (ie, RAVE) and data analysis tools (ie, J- Review ) requiredStrong medical writing and presentation skillsBasic understanding of… more
- Insmed Incorporated (NJ)
- …and manage strategic supplier relationships, lead vendor selection, performance monitoring , business review governance, and continuous improvement ... representative on cross-functional project and clinical strategy teams; translate protocol design into demand/supply plans, contingency strategies, and risk… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …expertise, guidance, and oversight to the operational units within the CTO (clinical, regulatory, protocol review and monitoring , data safety monitoring , ... to implement system wide changes. + Participates in audit debriefings, review all audit/ monitoring visit reports, and collaborates with the CTO management… more
- University of Colorado (Aurora, CO)
- …+ Colorado Multiple Institutional Review Board (COMIRB) + Protocol Review and Monitoring System (PRMS) + Hospital Research Support Services ... firms or in-house staff for initial orientation to studies and for review of regulatory records. + Submits complete and accurate clinical research applications… more
- Dana-Farber Cancer Institute (Boston, MA)
- …management, biobanking, electronic data capture, protocol review and monitoring , grant development, intellectual property, and other systems supported by ... enthusiastic Business Analyst II to coordinate, manage and support the information system needs of the Dana-Farber Cancer Institute (DFCI) research community. The… more
- Kelly Services (Bethesda, MD)
- …in the world. We are seeking individuals qualified to work as a **Clinical Protocol Coordinator** to support the mission of the National Institutes of Health (NIH). ... including but not limited to roster issues, DCTD-Audit Information System (AIS) business rules and enhancements, and other issues...on the preparation of regulatory documents as required for protocol approval by FDA, CTEP, IRB, OPRR and drug… more
- Mount Sinai Health System (New York, NY)
- …validations with study teams. + Verify that data is submitted with all required protocol and subject information. + Analyze and review data in the OnCore ... study team members to collect and verify clinical research protocol and accrual data. The Program Coordinator will be...System is one of the largest academic medical systems in the New York metro area, with more… more
- Terumo Neuro (Aliso Viejo, CA)
- …and reviewing essential documents, facilitating necessary corrections, and filing in assigned system (s). + Maintain device accountability records. + Review data ... **12869BR** **Title:** Sr Associate, Field Clinical Monitoring (US Remote) **Job Description:** Responsible for driving...Ensure clinical studies are conducted in accordance with the protocol , GCP, company SOPs, and all applicable regulations (eg,… more
- Mount Sinai Health System (New York, NY)
- …and unanticipated events to institutional offices and committees (ie Data safety monitoring , institutional review board, etc.) + Facilitates in/external ... Responsibilities: + Provides exemplary patient care while ensuring the protocol is conducted in a high-quality manner and clinical...System is one of the largest academic medical systems in the New York metro area, with more… more
- Mount Sinai Health System (New York, NY)
- …clinical research data. Prepares grant applications and documents and assists in protocol submissions (for eg, Institutional Review Board, Grants and Contracts ... and management of patient clinical information, timely collection of protocol related samples including shipment to outside entities as...System is one of the largest academic medical systems in the New York metro area, with more… more
