Job Description
Join our pioneering team at MediCure Solutions, where innovation meets healthcare excellence. We're seeking a dedicated Clinical Research Associate to drive breakthroughs in clinical trials while ensuring regulatory compliance and data integrity. Work alongside world-class physicians and scientists in our state-of-the-art Boston facility, contributing to life-changing therapies that impact millions globally. Enjoy competitive benefits, professional development opportunities, and a collaborative environment that values your expertise.
Responsibilities
- Oversee clinical trial protocols and site monitoring activities across multiple research centers
- Ensure FDA, ICH-GCP, and HIPAA compliance throughout trial phases
- Manage electronic data capture systems and maintain accurate patient records
- Collaborate with investigators to resolve protocol deviations and ensure patient safety
- Prepare regulatory submissions and audit documentation for FDA reviews
- Analyze clinical trial data and prepare comprehensive study reports
- Train clinical staff on trial protocols and ethical research practices
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 Associate (CCRA) or ACRP certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave)
- Deep knowledge of FDA regulations and ICH-GCP guidelines
- Exceptional attention to detail and documentation skills
- Strong problem-solving abilities and cross-functional collaboration experience