Job Description
Join BioPharm Innovations, a leader in cutting-edge therapeutics, as we pioneer the next generation of life-changing treatments. We're seeking a dedicated Senior Clinical Research Associate to drive excellence in clinical trial execution and regulatory compliance. This role offers the opportunity to work with multidisciplinary teams across our state-of-the-art facilities in Boston's biotech hub, contributing directly to therapies that impact global health outcomes.
As a key member of our Clinical Operations team, you'll ensure trials adhere to GCP guidelines while maintaining the highest ethical standards. We offer competitive compensation, comprehensive benefits, and a dynamic environment where innovation thrives. If you're passionate about accelerating drug development and making tangible differences in patients' lives, we encourage you to apply.
Responsibilities
- Oversee clinical trial execution across multiple sites, ensuring protocol adherence and data integrity
- Conduct site initiation, monitoring, and closeout visits with meticulous attention to regulatory requirements
- Manage investigator relationships and communications to resolve issues proactively
- Review and analyze clinical data to identify trends and ensure compliance with study protocols
- Prepare regulatory documents including IB updates, safety reports, and trial amendments
- Collaborate with cross-functional teams to optimize trial design and operational efficiency
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 3+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) certification required
- Deep knowledge of ICH-GCP, FDA regulations, and clinical trial methodologies
- Exceptional problem-solving skills and attention to detail
- Strong proficiency in EDC systems (e.g., Medidata Rave) and clinical databases
- Proven ability to manage multiple trials and competing priorities
- Excellent written and verbal communication skills