Job Description
Join our pioneering team at Apex BioPharm Solutions, where innovation meets life-changing therapies. We're seeking a dedicated Senior Clinical Research Associate to drive our next-generation drug development initiatives. In this impactful role, you'll ensure regulatory compliance while accelerating breakthrough treatments to market. Our state-of-the-art Cambridge facility offers cutting-edge resources and collaborative opportunities with industry leaders. Enjoy competitive benefits, flexible work arrangements, and the chance to shape the future of medicine.
Responsibilities
- Design, implement, and oversee clinical trial protocols adhering to ICH-GCP and FDA regulations
- Monitor site performance, conduct site visits, and audit trial documentation
- Lead cross-functional teams to ensure protocol compliance and data integrity
- Develop risk-based monitoring strategies and manage clinical budgets
- Interpret complex medical data and prepare regulatory submissions
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- MSc/PhD in Pharmacy, Life Sciences, or related field with 5+ years clinical research experience
- Certified CRA (ACRP/SoCRA) or equivalent certification required
- Proven expertise in Phase I-III oncology or rare disease trials
- Strong knowledge of FDA 21 CFR Part 11 and EMA regulations
- Exceptional project management and vendor management skills
- Advanced proficiency in clinical trial management systems (e.g., Medidata Rave)