Clinical Research Associate

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