Job Description
Join our pioneering team at MediCare Solutions Group, where we're transforming patient outcomes through innovative clinical trials. As a Senior Clinical Research Coordinator, you'll lead complex studies at our Boston facility, collaborating with multidisciplinary teams to ensure regulatory compliance and data integrity. We offer competitive benefits, professional development opportunities, and a culture that values scientific excellence and patient-centered care.
Responsibilities
- Design and execute clinical trial protocols adhering to FDA regulations and ICH-GCP standards
- Recruit, screen, and enroll qualified participants while maintaining ethical research practices
- Manage comprehensive trial documentation including case report forms and regulatory submissions
- Analyze and interpret clinical data using statistical software and generate study reports
- Coordinate cross-functional teams including physicians, biostatisticians, and regulatory affairs specialists
- Monitor adverse events and ensure timely safety reporting to institutional review boards
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of clinical trial coordination experience with Phase II-III studies
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave, Veeva Vault)
- Demonstrated expertise in regulatory compliance and audit readiness
- Strong statistical analysis skills using SAS or R programming
- Experience with oncology or cardiovascular therapeutic areas preferred