Inhouse Clinical Research Associate - Australia
Core
Provides in-house support to the clinical team for project requirements, ensuring compliance with ICH GCP guidelines and regulatory standards.
Role type
Inhouse Clinical Research Associate
Builds
Clinical study documentation, Trial Master Files, Investigator Site Files, and Clinical Trial Management System data
Domain
Clinical research / Life Sciences
Required skills
Clinical study documentation management, Trial Master File (TMF) maintenance, Clinical Trial Management System (CTMS) management, Investigator Site File creation, Trial material logistics, Regulatory compliance (ICH GCP), Document development and collection
Preferred skills
Life Sciences or related field experience, Pharmaceutical/CRO/healthcare industry experience
Responsibilities
Coordinate and maintain clinical study documentation in the Trial Master Files (TMF), Manage the Clinical Trial Management System (CTMS), Create the Investigator Site Files and coordinate trial materials, Assist CRAs with monitoring visit preparations, Assist with IRB submissions and safety reporting
Seniority
Junior, entry-level
