Job Description
Join BioPharm Innovations LLC, a leader in groundbreaking pharmaceutical research, as we pioneer the next generation of therapeutics. We seek a Senior Clinical Research Associate to oversee critical clinical trials, ensuring compliance with FDA regulations and GCP standards. This role offers the opportunity to shape the future of medicine while collaborating with top-tier scientists and medical professionals in our state-of-the-art Boston facility.
Responsibilities
- Design and implement clinical trial protocols in alignment with FDA guidelines
- Monitor investigational sites for protocol adherence and data integrity
- Lead site initiation, interim monitoring, and closeout visits
- Analyze clinical data and prepare regulatory submissions (IND/CTA)
- Mentor junior CRAs and conduct investigator training sessions
- Collaborate with cross-functional teams (medical, biostatistics, regulatory)
Qualifications
- Bachelor's degree in Pharmacy, Nursing, or Life Sciences (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials
- CRA certification (ACRP/SoCRA) or equivalent
- Expertise in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Proven track record in FDA audit preparation and response
- Strong knowledge of ICH-GCP and 21 CFR Part 312
- Exceptional problem-solving and stakeholder management skills