Job Description
Join BioPharm Innovations at the forefront of medical breakthroughs as a Senior Clinical Research Associate in our Cambridge, MA headquarters. We're seeking a passionate professional to oversee complex clinical trials, ensuring regulatory compliance and data integrity while collaborating with cross-functional teams to accelerate therapeutic innovations. This role offers the opportunity to shape the future of medicine in a dynamic, research-driven environment.
Responsibilities
- Design, implement, and monitor clinical trial protocols in compliance with FDA/ICH/GCP standards
- Lead site management activities including investigator training and site initiation visits
- Analyze clinical data and prepare comprehensive study reports for regulatory submissions
- Coordinate cross-functional teams (medical, regulatory, biostatistics) to ensure trial milestones
- Manage clinical trial documentation and maintain audit-ready study files
- Identify and mitigate risks through proactive site monitoring and quality control measures
Qualifications
- Master's degree in Pharmacy, Nursing, Life Sciences, or related field (or equivalent experience)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in EDC systems (e.g., Medidata Rave) and CTMS platforms
- Strong knowledge of 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional communication skills for stakeholder management across global teams
- Ability to travel up to 30% for site visits and conferences