|Contract Senior Clinical Research Associate|
Role: Senior Clinical Research Associate
Location: Irvine, CA
Therapeutic Area: Neurovascular – Medical Device
Duration: 12 Month Contract
- Provides study management as the Project Leader
- Assures successful conduct of assigned clinical studies consistent with R&D and Marketing plans and applicable regulations and policies.
- Interfaces with representatives from key functional groups including Clinical Affairs, Quality Affairs, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and European Clinical Groups.
- Works with Director of Clinical Affairs to ensure study objectives, strategy, scope and schedule meet business needs.
- Provides clinical interface with regulatory agencies, including pre-IDE meetings with the FDA
- Minimum 4-7 years experience directly supporting clinical research or similar experience in a medical/scientific area.
- Experience with direct reports and mentoring others
- High attention to detail and accuracy.
- Able to identify problems, develop solutions and implement to address study issues
- Expertise with GCPs and regulatory compliance guidelines for clinical trials.
Contract Senior Clinical Research Associate