(Senior) CRA
On-siteHome, Washington, United States
Job Summary
Conduct monitoring activities for oncology and hematology clinical trials, managing site startup, recruitment, data collection, and closeout while ensuring adherence to GCP, ICH, and local regulations. Deliver data within timelines and quality standards by performing routine visits, quality oversight visits, and co-monitoring as required. Manage site queries, regulatory submissions, and CRF completion, facilitating contract negotiations and assisting with investigator identification. Provide protocol training to sites, establish communication channels with investigators and contract monitor officers, and track site performance metrics. Collaborate with the CRA group to execute contingency plans and escalate quality issues. Bachelor's degree in life sciences or related field with over one year of monitoring experience; fluent in English. Competitive compensation, bonus, and shares.
Required Qualifications
- Bachelor's level degree or above in life sciences, pharmacy, nursing or medical
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- +1 year (Over 4 years for SCRA) of monitoring experience in the pharmaceutical or CRO industry
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English (writing and speaking)
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.