Clinical Research Associate II / III - NZ
Core
Ensure rights and wellbeing of trial participants are protected and reported trial data are accurate, complete, and verifiable from source documents.
Role type
Senior Clinical Research Associate (CRA III/SCRA)
Builds
Clinical trials for pharmaceutical/biotech clients
Domain
Clinical research / Oncology
Deliverable
physical/clinical work
Required skills
Independent monitoring, site relationship management, regulatory compliance (ICH GCP), participant recruitment, site selection, site initiation, site close-out, unblinded pharmacy visits, co-monitoring visits
Preferred skills
Oncology experience
Technologies
None stated
Responsibilities
Build relationships with Principal Investigators, study coordinators, pharmacists, and site personnel; Foster internal and external customer relationships for efficient project delivery; Collaborate with IHCRA and RSA to prepare site essential documents and support ethics/regulatory submissions; Understand local and international regulatory requirements; Ensure recruitment of participants as per site targets; Monitor investigational sites across all phases including Site Selection, Site Initiation, Site Monitoring, Site Close Out, unblinded pharmacy visits, and co-monitoring visits.
