Job Description
Join NovoMed Therapeutics, a leader in innovative pharmaceutical solutions, as we pioneer next-generation therapies. We seek a Senior Clinical Research Associate to drive excellence in clinical trial execution and regulatory compliance. This pivotal role combines scientific rigor with strategic oversight to accelerate life-changing treatments to market. Enjoy competitive compensation, cutting-edge resources, and a collaborative environment where your expertise directly impacts global health outcomes.
Responsibilities
- Oversee clinical trial protocols, site monitoring, and data integrity across Phase I-III studies
- Ensure FDA/ICH/GCP compliance through rigorous site audits and documentation review
- Coordinate cross-functional teams (medical, regulatory, data management) to meet trial milestones
- Develop risk-based monitoring strategies and site selection criteria
- Lead investigator meetings and training sessions on clinical procedures
- Manage vendor relationships and study budgets for assigned trials
- Generate comprehensive trial reports for regulatory submissions
Qualifications
- Master's degree in Pharmacy, Life Sciences, or Clinical Research with 5+ years' CRA experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven expertise in oncology or immunology therapeutic areas
- Strong knowledge of 21 CFR Part 312, ICH-GCP, and FDA regulations
- Exceptional data management and eCRF proficiency
- Excellent communication skills for cross-stakeholder collaboration
- Ability to travel 30-40% for site visits and conferences
- Experience with risk-based monitoring (RBM) methodologies