Job Description
Join NovoMed Therapeutics, a pioneering biotech firm dedicated to transforming patient care through innovative therapies. We seek a Senior Clinical Research Associate to lead complex clinical trials and drive regulatory compliance excellence. This role offers the opportunity to shape the future of pharmaceutical innovation while working alongside world-class scientists in our state-of-the-art Cambridge facility.
Responsibilities
- Design and execute Phase I-III clinical trials ensuring adherence to FDA/ICH-GCP standards
- Manage investigator relationships and site monitoring activities across 15+ global sites
- Oversee clinical data integrity through protocol deviation management and source document verification
- Prepare regulatory submissions including INDs, annual reports, and safety updates
- Lead cross-functional teams (medical, regulatory, biostatistics) to achieve trial milestones
- Implement risk-based monitoring strategies to optimize trial efficiency and compliance
- Maintain electronic trial master files and audit readiness documentation
Qualifications
- Master’s degree in Life Sciences, Pharmacy, or Nursing (PhD preferred)
- 5+ years of clinical research experience with 2+ years in a lead CRA role
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in eClinical systems (Veeva Vault RIM, Medidata Rave)
- Exceptional audit management experience with FDA/EMA inspections
- Strong analytical skills with ability to interpret complex clinical data
- Ability to travel 30% domestically/internationally for site visits