Clinical Research Associate II
On-siteLouisville, Kentucky, United States
Job Summary
Conduct ongoing study monitoring including frequent periodic site visits, protocol adherence checks, and material handling procedures. Initiate studies by performing initiation site visits, arranging shipment of clinical supplies and case report forms, and procure budgets, contracts, and regulatory documents. Participate in protocol design, generate clinical SOPs, and evaluate potential clinical sites. Prepare site visit reports identifying key accomplishments, issues, and follow-up actions, and conduct study termination visits to obtain final reports from investigators. Assist with maintenance of clinical archive and electronic files. Requires BA, BS, RN, or BSN with 1-2 years of 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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