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
