and outpatient settings. Acts as liaison between functions (i.e. PM, investigator, research team, etc.). Ensures client requirements...
development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject...
between the Sponsor, the Investigator and the research team. Ensures client requirements and specifications are communicated... register throughout the study; works with the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized...
in Phase I research studies. Provides the Informed Consent Session as delegated by the Principal Investigator. Prepares...
activities, including investigator outreach, site readiness, and quality checks. Prepare and present training materials... for investigator meetings and site sessions. Assist with data transfers, invoicing, and resolution of study holds or alerts...
level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI...
documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs) Lead projects...
in person-to-person and small group situations with the Principal Investigator, Project Archaeologist, and other employees...