Clinical Research Associate II
On-siteSeattle, Washington, United States
Job Summary
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, and material handling procedures. Assist in design and preparation of protocols and case report forms, while generating clinical SOPs, policies, charters, and plans according to US and international guidelines. Initiate studies by performing initiation site visits, arranging shipment of clinical supplies, and procuring budgets, contracts, and regulatory documents. Prepare site visit reports identifying key accomplishments, issues, and recommendations for follow-up actions. Conduct study termination visits, obtain final reports from investigators, and assist in preparing final reports for regulatory submission. Maintain clinical archive and electronic files. Requires BA/BS/RN degree, 1-2 years clinical research experience, and adherence to GCPs.
Required Qualifications
- BA, BS, RN, BSN or equivalent
- Basic knowledge and adherence to GCPs
- 1-2 years of clinical research experience or equivalent experience or training
- Strong attention to detail
- Ability to multi-task
- Unquestionable integrity and highest ethical standards
- Excellent written and verbal communication skills
- Self-motivated, assertive, and driven
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