Job Description
Join BioMed Innovations at the forefront of pharmaceutical breakthroughs! We're seeking a dynamic Senior Clinical Research Associate to lead critical clinical trials that transform patient lives. In this pivotal role, you'll design protocols, monitor trial integrity, and ensure compliance with FDA/ICH-GCP standards while collaborating with cross-functional teams to accelerate drug development. Our Cambridge campus offers cutting-edge labs and a culture where innovation meets impact.
Responsibilities
- Design, implement, and oversee clinical trial protocols across Phase I-III studies
- Monitor investigational sites for protocol compliance, data integrity, and regulatory adherence
- Lead site initiation, interim monitoring, and close-out visits with 95% audit readiness
- Collaborate with medical teams to analyze safety data and escalate critical findings
- Prepare regulatory documents (IB updates, safety reports) with zero-defect standards
- Mentor junior CRAs and optimize clinical trial workflows using eClinical solutions
Qualifications
- BS/MS in Life Sciences, Pharmacy, or Clinical Research with 5+ years' CRA experience
- ICH-GCP/FDA 1572 certification with proven audit success
- Therapeutic expertise in oncology or rare diseases preferred
- Advanced proficiency in CTMS and electronic data capture systems (Medidata Rave)
- Certified Clinical Research Professional (CCRP) or equivalent credential required
- Demonstrated leadership in managing 15+ multi-site trials