Clinical Research Associate II
Company: ClinLab Solutions Group Agency
- Location: United States
- Seniority: Mid level
- Employment type: Full-time
- Posted: 11 days ago
- Offer language: English
Job description
This is an in house CRA II role supporting a complex implantable IDE trial. The CRA II will conduct pre study visits including Site Qualification Visits and Site Initiation Visits, build and maintain close relationships with study sites through on site and remote monitoring, verify data on CRFs against participant clinical notes and surgical records, and manage close out visits. This role also includes writing accurate and timely visit reports, overseeing device accountability, independently managing IRB, EC, and Regulatory Authority submissions through approval, preparing annual trial progress reports, and assisting sites with Serious Adverse Event reporting. The CRA II will independently perform UAT of EDC systems, manage CTMS or eTMF systems, prepare training materials, contribute to SOP development, and provide on the job training and co-monitoring support to CRA I team members.
Qualifications include a B.S. or higher in a science related field or equivalent industry experience, at least 5+ years of clinical research experience specifically in medical device trials, strong knowledge of US FDA CFR and GCP guidelines, and willingness to travel more than 50%.
