What are the responsibilities and job description for the Clinical Research Associate (CRA) position at Gandiv Insights LLC?
Job Title: Clinical Research Associate (CRA)
Location: Atlanta, Georgia, United States
Employment Type: Contract (W2 Only)
Job Summary:
We are seeking a Clinical Research Associate (CRA) to monitor and support clinical trials in compliance with GCP, FDA, and ICH guidelines. This role ensures clinical studies are conducted according to protocol, regulatory requirements, and company standards.
Key Responsibilities:
- Monitor clinical trial sites to ensure compliance with protocol and regulations
- Conduct site initiation, monitoring, and close-out visits
- Review and verify clinical data and source documentation
- Ensure adherence to ICH-GCP, FDA, and IRB requirements
- Track study progress, patient enrollment, and data quality
- Support audit and inspection readiness
Required Qualifications:
- Bachelor’s degree in Life Sciences or related field
- 2–5 years of CRA experience in pharma or clinical research
- Strong knowledge of ICH-GCP and FDA regulations
- Experience with site monitoring and clinical documentation
- Strong communication and organizational skills
Kindly send your updated resume to anitha@gandivainsights.com