Job Description
Join BioPharm Solutions Inc., a leader in innovative drug development, as a Senior Clinical Research Associate. You will play a pivotal role in advancing life-changing therapies by ensuring clinical trials adhere to regulatory standards and deliver high-quality data. Our Cambridge headquarters offers cutting-edge laboratories and collaborative teams dedicated to transforming patient outcomes. This hybrid role combines strategic oversight with hands-on trial management, offering competitive compensation and growth opportunities in one of the world's premier biotech hubs.
Responsibilities
- Oversee clinical trial execution, ensuring compliance with GCP, FDA regulations, and protocol requirements
- Manage investigator relationships and site monitoring activities across multiple trial phases
- Lead risk-based monitoring strategies and conduct comprehensive site visits/audits
- Prepare and submit regulatory documents, including safety reports and trial amendments
- Collaborate with cross-functional teams (medical, biostatistics, data management) to resolve trial issues
- Mentor junior CRAs and contribute to process improvements in clinical operations
- Ensure accurate data collection and reporting in electronic systems (EDC/Rave)
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field; Master's preferred
- Minimum 5 years of clinical research experience with 2+ years in CRA role
- ICH-GCP and FDA regulatory compliance expertise
- Proven experience monitoring Phase II-III clinical trials in therapeutic areas (oncology/neurology a plus)
- Exceptional organizational skills with ability to manage multiple complex trials
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and clinical trial management software
- Certification as a CRA (ACRP or SoCRA) required
- Ability to travel 25-30% domestically