Job Description
Join NovoMed Therapeutics as a Senior Clinical Research Associate and lead transformative clinical trials that shape the future of medicine. We're pioneering breakthrough therapies in oncology and rare diseases, and we need your expertise to ensure our studies meet the highest regulatory and ethical standards. This role offers hybrid flexibility and the opportunity to collaborate with world-class scientists and regulatory experts.
Responsibilities
- Oversee site selection, initiation, and monitoring of Phase I-III clinical trials
- Ensure protocol compliance and FDA/ICH-GCP adherence across global sites
- Manage clinical trial documentation, including CRFs, SAEs, and regulatory submissions
- Lead cross-functional collaboration with data management, biostatistics, and medical teams
- Conduct site visits, audits, and vendor management to ensure data integrity
- Mentor junior CRAs and optimize clinical trial processes
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (MS/PhD preferred)
- 5+ years of clinical research experience with 2+ years in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expert knowledge of FDA regulations, ICH-GCP, and clinical trial methodologies
- Strong problem-solving skills and attention to detail in documentation
- Experience with EDC systems (e.g., Medidata Rave) and clinical trial management software