Job Description
Join NovoMed Therapeutics, a leader in innovative drug development, as we pioneer breakthrough therapies in oncology and immunology. We seek a meticulous Senior Clinical Research Associate to oversee critical Phase II/III trials across our Cambridge headquarters. This hybrid role (3 days in-office) offers the opportunity to shape the future of medicine while collaborating with world-class scientists and regulatory experts. Enjoy competitive benefits, including equity participation in our pipeline of FDA-candidate therapies.
Responsibilities
- Monitor 15+ global clinical trial sites for protocol compliance and data integrity
- Lead FDA inspections and regulatory submissions for oncology trials
- Develop and implement risk-based monitoring strategies using eClinical platforms
- Mentor junior CRAs and coordinate cross-functional team activities
- Analyze clinical data to identify safety signals and efficacy trends
- Prepare audit-ready documentation and site visit reports
- Collaborate with biostatisticians on protocol amendments and endpoint definitions
Qualifications
- BS/MS in Pharmacy, Life Sciences, or related field with 5+ years clinical research experience
- CRA certification (ACRP/SoCRA) and GCP training certification
- Proven expertise in oncology/immunology clinical trials
- Advanced proficiency in Medidata Rave and Oracle CTMS
- Strong knowledge of FDA/ICH-GCP regulations and 21 CFR Part 11
- Exceptional audit management and site closure experience
- Excellent written communication for regulatory documents
- Ability to travel domestically 30% of time