Job Description
Join NovoMed Therapeutics, a global leader in innovative pharmaceutical solutions, as we pioneer next-generation therapies for life-altering diseases. We seek a passionate Senior Clinical Research Associate to drive excellence in clinical trial execution and regulatory compliance. This pivotal role offers the opportunity to shape the future of healthcare while collaborating with world-class scientists and medical professionals in our state-of-the-art Boston facility.
Responsibilities
- Oversee end-to-end clinical trial management, including site selection, initiation, monitoring, and closeout activities
- Ensure strict adherence to ICH-GCP guidelines, FDA regulations, and protocol specifications
- Lead cross-functional collaboration with biostatisticians, data managers, and regulatory affairs teams
- Conduct comprehensive site visits, audits, and vendor management to maintain data integrity
- Develop and maintain risk-based monitoring strategies and clinical trial documentation
- Mentor junior CRAs and contribute to process optimization initiatives
Qualifications
- Bachelor's degree in life sciences, nursing, or related field; Master's preferred
- 5+ years of clinical research experience with Phase I-III trials
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in oncology or rare disease therapeutic areas
- Exceptional data management and eCRF proficiency
- Strong problem-solving skills and regulatory navigation experience
- Excellent communication abilities with global stakeholders