Job Description
Join NovoMed Therapeutics, a pioneering biopharmaceutical company dedicated to developing transformative therapies for rare diseases. As a Senior Clinical Research Associate, you'll play a pivotal role in advancing our Phase II-III oncology trials, ensuring regulatory compliance while driving innovation in clinical operations. Collaborate with cross-functional teams to shape trial protocols, monitor site performance, and contribute to life-changing research. Enjoy competitive benefits, flexible work arrangements, and opportunities for professional growth in a dynamic, mission-driven environment.
Responsibilities
- Design and implement comprehensive monitoring strategies for Phase II-III oncology clinical trials
- Conduct site visits to ensure protocol adherence, GCP compliance, and data integrity
- Collaborate with CROs and investigative sites to resolve protocol deviations and operational challenges
- Analyze clinical data trends and provide actionable insights to improve trial efficiency
- Develop risk-based monitoring plans and lead vendor management activities
- Maintain up-to-date knowledge of ICH-GCP, FDA regulations, and industry best practices
- Mentor junior CRAs and contribute to process optimization initiatives
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field (MS/PhD preferred)
- 5+ years of clinical monitoring experience in oncology or rare disease trials
- Certified CRA (CCRA) or equivalent regulatory certification required
- Proven expertise in risk-based monitoring and eTMF management
- Strong analytical skills with proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional communication and stakeholder management abilities
- Ability to travel up to 40% for site visits and conferences
- Experience with FDA audits and regulatory inspections