Job Description
Join MediCure Innovations, a leader in cutting-edge medical research, as a Clinical Research Associate. You'll be pivotal in advancing patient care through rigorous clinical trials, ensuring compliance with FDA regulations and GCP standards. Our collaborative environment offers competitive compensation, comprehensive benefits, and opportunities for professional growth in Boston's thriving healthcare ecosystem.
Responsibilities
- Monitor clinical trial sites to ensure protocol adherence and data integrity
- Coordinate with investigators, sponsors, and regulatory bodies
- Review medical documentation for accuracy and compliance
- Manage adverse event reporting and risk mitigation
- Prepare regulatory submissions and maintain audit-ready documentation
- Liaise with cross-functional teams to resolve trial-related issues
- Analyze trial data to support clinical decision-making
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 3+ years of clinical research experience with FDA-regulated trials
- Certified Clinical Research Associate (CCRA) certification
- Proficiency in EDC systems and clinical trial management software
- Deep understanding of ICH-GCP and FDA regulations
- Exceptional attention to detail and documentation skills
- Strong communication and problem-solving abilities
- Ability to travel up to 30% to clinical sites