Job Description
Join our cutting-edge team at BioPharm Innovations, where we pioneer breakthrough therapies to transform global healthcare. We're seeking a meticulous Clinical Research Associate to ensure the integrity and compliance of our clinical trials, directly impacting patient lives and regulatory approvals. Enjoy competitive benefits, flexible work arrangements, and opportunities for professional growth in one of Boston's premier biotech hubs.
Responsibilities
- Monitor clinical trial sites for protocol adherence and regulatory compliance (FDA, ICH-GCP)
- Conduct site visits, source document verification, and data quality audits
- Manage investigator relationships and provide GCP training to site staff
- Prepare comprehensive study reports and regulatory submissions
- Collaborate with cross-functional teams to resolve protocol deviations
- Track trial milestones and escalate risks per SOPs
- Maintain electronic trial master files and audit trail documentation
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field
- Certified Clinical Research Associate (CCRA) or equivalent certification required
- 3+ years of CRA experience in Phase II-III pharmaceutical trials
- Proven expertise in oncology or immunology therapeutic areas
- Advanced knowledge of FDA regulations and ICH-GCP guidelines
- Exceptional audit report writing and site management skills
- Valid driver's license with willingness for 30% travel
- Proficiency in CTMS systems (e.g., Medidata Rave, Veeva Vault)