Spec 3, Clinical Research at MillenniumSoft Inc — NeverHard
Spec 3, Clinical Research at MillenniumSoft Inc in East Irvine, Orange County. Skills: CTMS, Clinical Studies, GCP, Regulatory requirements, SOPs. Apply on NeverHard.
Company
MillenniumSoft Inc
Location
East Irvine, Orange County
Type
not_specified
Required skills:
CTMS
Clinical Studies
GCP
Regulatory requirements
SOPs
Trial Master File (TMF)
data review
eTMF Systems
The main function of the Clinical Research Specialist is to support clinical study start up, execution, and closeout with a strong emphasis on maintaining an inspection ready Trial Master File (TMF). Responsibilities include organizing, reviewing, and quality checking essential documents in the eTMF and CTMS to ensure compliance with GCP, regulatory requirements, and internal SOPs. The Specialist identifies and investigates documentation discrepancies, supports data review and query resolution …