Job Description
Join MediCore Solutions, a leader in innovative medical research, as we pioneer breakthrough treatments for global health challenges. We seek a meticulous Clinical Research Associate to ensure our trials meet the highest ethical and regulatory standards while accelerating life-changing therapies to market. Enjoy competitive benefits, cutting-edge resources, and the opportunity to impact patient lives directly.
Responsibilities
- Monitor clinical trial protocols, site compliance, and data integrity across 3-5 research sites
- Conduct site visits, source document verification, and audit sponsor documentation
- Collaborate with investigators to resolve protocol deviations and ensure GCP adherence
- Prepare comprehensive study reports and regulatory submissions (FDA/EMA)
- Train site staff on trial procedures and electronic data capture systems
- Analyze adverse events and safety data for risk mitigation strategies
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 2+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of ICH-GCP, FDA 21 CFR, and EU regulations
- Exceptional attention to detail and documentation skills
- Valid driver's license and willingness to travel 30% of the time