- University of Iowa Hospitals & Clinics (Iowa City, IA)
- … investigator . Contribute to safety program documentation and maintain compliance records. Support grant application processes, including data collection and the ... and competency testing standards while maintaining meticulous records in compliance with regulatory requirements. Research Support: Conduct literature reviews to… more
- Beth Israel Lahey Health (Boston, MA)
- …a difference in people's lives. The Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC). ... Core The Clinical Research Coordinator Core provides support for investigator -initiated and sponsor-initiated research for investigators across the departments and… more
- Glycomine (Boston, MA)
- …adherence to contractual agreements, timelines and quality standards Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs ... the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …Medical Affairs Company Sponsored Studies (MACS) collaborative studies and Investigator Initiated Research (IIR). Specific objectives include: Partners with Head ... within assigned TA in accordance with all applicable internal legal and compliance policies as well as external US-specific regulatory guidelines. Partners with US… more
- Revolution Medicines (Redwood City, CA)
- …role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed's ... clinical functions (eg, Clinical Operations, Clinical Development) to provide GCP compliance support. Participate in clinical study execution teams (CSETs) to enable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study teams to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials and managed access programs to the highest quality ... for specialty pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned,… more
- Galderma SA (Boston, MA)
- …for data generation activities through proposals for posthoc analyses, Investigator -Initiated Trial (IIT), and Medical Affairs-sponsored studies for research that ... stakeholders are conducted timely and with strict adherence to legal and compliance guidelines. Provide medical and scientific support into the planning and… more
- Mount Sinai Hospital (Wantagh, NY)
- …as specified by the department SOP. Assists with QA/QC program ensuring compliance with all regulatory agency requirements. Assists physician directly as required ... of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's… more
- Mount Sinai Hospital (New York, NY)
- …for review and approval. Maintains departmental employee files, and ensures compliance with regulatory standards. Initiates and follows through on human resources ... of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's… more
- Children's Hospital Association - Saint Paul, MN (Minneapolis, MN)
- …Interviewer (CFI), Physical Security Professional (PSP), Professional Certified Investigator (PCI), a plus. Knowledge/Skills/Abilities: * Excellent verbal and ... of an occupational health assessment, drug screen, background investigation, and compliance with the US Government Form I-9, Employment Eligibility Verification.… more
