- Amergis (Columbia, MD)
- …unmatched staffing experiences to deliver the best workforce solutions. The BCBA Investigator plays a critical role in ensuring clinical quality and safety ... analyzing trends, and supporting policy and quality improvements. The BCBA Investigator collaborates with risk management, legal, compliance, and clinical ops to… more
- General Dynamics Information Technology (Fort Detrick, MD)
- …**regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.** **This is a hybrid position and will ... annual reports, information amendments, clinical protocols and study reports, investigator 's/investigational brochures, FDA meeting requests and background materials, responses… more
- Guidehouse (Bethesda, MD)
- …maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports. + Track and ... Research Coordinator. This position will provide clinical protocol and human subjects safety support and expertise to researchers and research support staff in the… more
- Guidehouse (Bethesda, MD)
- …consent forms. + Coordinate regulatory submissions including IDE applications, amendments, safety reports, and FDA annual reports. + Facilitate regulatory approvals ... and FDA guidelines. + Support study teams in navigating IRB, radiation safety , and other review processes. + Maintain regulatory documentation, track approvals, and… more