GBS C&H CLINICAL RESEARCH OPERATIONS SUPPORT
Core
Support clinical trial study document management and Institutional Review Board (IRB) submission processes within a Global Business Solutions center.
Role type
Clinical Research Operations Support
Builds
Clinical trial documentation and regulatory submissions
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
Required skills
Study document development, IRB submission management, protocol review support, SOP development, regulatory compliance, data quality focus, MS Office proficiency
Preferred skills
Project management experience, multi-project coordination, independent work
Technologies
MS Office
Responsibilities
Assist in developing study documents and preparing studies for initiation; Collaborate with Clinical Research Coordinators and Principal Investigators to ensure documentation aligns with protocol and GCP; Manage study status including submission, adverse event reporting, and study closure; Assist in reviewing and developing new protocols and standard operating procedures; Ensure compliance with regulations and internal policies.
Seniority
Entry-level to Junior
