Job Description
Join Harvard Medical Innovation Group at the forefront of groundbreaking clinical research. We're seeking a dynamic Senior Clinical Research Coordinator to lead complex clinical trials, ensuring data integrity, regulatory compliance, and patient safety while collaborating with multidisciplinary teams to advance medical breakthroughs.
Responsibilities
- Oversee end-to-end clinical trial management from protocol development to final reporting
- Ensure compliance with FDA regulations, GCP, and institutional guidelines
- Manage electronic data capture systems and maintain accurate patient records
- Liaise with investigators, sponsors, and regulatory bodies
- Mentor junior staff and optimize clinical trial workflows
- Analyze trial data and prepare regulatory submissions
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) required
- Expertise in EDC systems (e.g., Medidata Rave) and CDISC standards
- Strong knowledge of 21 CFR Part 11 and ICH-GCP guidelines
- Exceptional organizational and problem-solving skills
- Experience with oncology trials preferred