Job Description
Join BioMed Innovations Inc., a leading biotechnology pioneer at the forefront of groundbreaking therapies. As a Senior Clinical Research Associate, you'll drive the success of Phase I-III clinical trials in our state-of-the-art Cambridge facility. We're seeking a passionate professional to ensure protocol compliance, manage site relationships, and contribute to life-changing medical breakthroughs.
Our culture emphasizes scientific excellence, collaborative innovation, and career growth. Enjoy competitive benefits, flexible work arrangements, and the opportunity to impact global health initiatives.
Responsibilities
- Monitor clinical trial sites for protocol adherence and GCP compliance
- Manage investigator relationships and site performance metrics
- Oversee clinical trial data collection and quality assurance processes
- Coordinate regulatory submissions and ethical approvals
- Mentor junior CRAs and contribute to SOP development
- Analyze trial data and prepare regulatory documentation
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field
- 5+ years clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) preferred
- Expertise in FDA regulations and ICH-GCP guidelines
- Strong proficiency in EDC systems (e.g., Medidata Rave)
- Exceptional problem-solving and communication skills
- Ability to travel up to 30% for site monitoring