Job Description
Job OverviewRegulatory & Start Up Specialist, cFSP.Location: Mexico - Full home basedThis position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members.
This includes supporting site qualification, site level regulatory green light and site maintenance/close-outs.Essential FunctionsParticipate in development of in-house model process documents.For assigned sites and countries, serve as a primary site contact for end-to-end study activity.Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.Utilize systems and tools to track assigned activities and produce reports and metrics as needed.Oversee essential document collection, tracking & review.Support the collection of country and site level intelligenceSupport Ethics Committee and Regulatory Autho...