Clinical Research Associate 1
On-siteMiami, Indiana, United States
Job Summary
Support clinical study teams by assisting in protocol and case report form design, generating SOPs and plans, and evaluating potential sites. Manage procurement of budgets, contracts, and regulatory documents while initiating studies through site visits and material shipments. Conduct ongoing monitoring via periodic site visits, protocol adherence checks, and file inspections, then prepare reports detailing accomplishments and follow-up actions. Execute study termination visits, obtain final investigator reports, and assist in preparing regulatory submissions and maintaining clinical archives. Requires a BA/BS/RN, 1-2 years of clinical research experience, and adherence to GCPs. Offers dental, medical, vision, PTO, and 401K benefits.
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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