The CRA was responsible for site monitoring, working according to company SOPs and ICH/GCP requirements.

Core responsibilities included:

Conducting site qualification, site initiation, routine monitoring and closeout visits Training investigators and site staff during SIVs and on study updates Working with the CTM to address site noncompliance and corrective actions Supporting sites with patient recruitment and screening strategies Tracking site performance, including startup, enrollment, data collection and adverse-event documentation Partnering with CTAs/CRAs to collect and review essential documents and maintain the eTMF Supporting investigator meetings and study-related training Providing EDC and other ongoing study training to sites Managing investigational product and clinical supplies at assigned sites Ensuring appropriate collection, storage and shipment of laboratory specimens Participating in Clinical Trial Team meetings Experience they were looking for BA/BS in life sciences or a nursing degree 5+ years of relevant clinical research/healthcare experience At least 2 years of direct field-monitoring experience Independent monitoring experience across Phase 1, 2 and 3 trials Oncology experience highly preferred Knowledge of

GCP, ICH, 21

CFR, HIPAA and the drug-development/approval process Ability to conduct remote monitoring