Job Description
Join BioPharm Innovations Inc. at the forefront of medical breakthroughs as a Senior Clinical Research Associate. We're seeking a dedicated professional to lead pivotal clinical trials that transform patient outcomes. In this dynamic role, you'll collaborate with cross-functional teams to ensure regulatory compliance, data integrity, and protocol adherence throughout the drug development lifecycle. Our Boston-based hub offers cutting-edge facilities, mentorship from industry leaders, and opportunities to shape the future of therapeutics.
Responsibilities
- Design and execute clinical trial protocols ensuring FDA/ICH-GCP compliance
- Monitor investigational sites for protocol adherence and data quality
- Liaise with regulatory agencies and ethics committees for submissions
- Analyze clinical data and prepare comprehensive study reports
- Mentor junior associates and optimize clinical trial workflows
- Collaborate with biostatisticians on endpoint validation
- Manage vendor relationships for clinical trial supplies
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field
- 5+ years clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent
- Proven expertise in EDC systems (e.g., Medidata Rave)
- Strong knowledge of 21 CFR Part 11 and ICH-GCP guidelines
- Experience with oncology or rare disease trials preferred
- Exceptional problem-solving and stakeholder management skills
- Ability to travel 30-40% domestically/internationally