Job Description
Join MediGenix Research Institute, a leader in cutting-edge clinical trials, as we pioneer breakthrough therapies in oncology and immunology. We seek a meticulous Clinical Research Associate to ensure protocol compliance and data integrity across multi-center studies. Enjoy competitive compensation, comprehensive benefits, and opportunities to contribute to life-changing medical innovations.
Responsibilities
- Monitor clinical trial sites for adherence to GCP standards and protocols
- Conduct site visits, source data verification, and audit trial documentation
- Coordinate investigator meetings and regulatory submissions
- Analyze adverse events and ensure timely safety reporting
- Maintain electronic trial master files and regulatory documentation
- Liaise with sponsors, ethics committees, and investigative sites
- Train site staff on protocol requirements and study procedures
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field
- Certified Clinical Research Associate (CCRA) certification preferred
- 3+ years of clinical trial monitoring experience in oncology trials
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of FDA 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional attention to detail and problem-solving skills
- Ability to travel up to 40% of the time
- Excellent written and verbal communication abilities