Job Description
Join NovoPharm Solutions as a Senior Clinical Research Associate and lead groundbreaking pharmaceutical studies at our state-of-the-art facility in Princeton, NJ. We're seeking a passionate professional to ensure clinical trials adhere to FDA regulations, GCP standards, and ethical protocols while driving innovative drug development from Phase I to Phase III.
Why Join Us? Enjoy competitive benefits, cutting-edge research resources, and a collaborative environment where your expertise directly impacts patient outcomes. Our commitment to scientific excellence and employee growth makes us a leader in pharmaceutical innovation.
Responsibilities
- Design, implement, and oversee clinical trial protocols ensuring compliance with FDA regulations and ICH-GCP standards
- Monitor investigational sites for protocol adherence, data integrity, and regulatory compliance
- Lead site initiation visits, interim monitoring, and close-out activities with 100% audit readiness
- Analyze clinical data and prepare comprehensive study reports for regulatory submissions
- Collaborate with cross-functional teams (medical, regulatory, biostatistics) to resolve protocol deviations
- Mentor junior CRAs and conduct investigator training on study procedures and safety reporting
- Develop and maintain risk-based monitoring strategies for complex therapeutic areas
Qualifications
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related field (Master's preferred)
- Minimum 5 years of clinical research experience with at least 2 years in CRA role
- Certified Clinical Research Professional (CCRP) or SOCRA certification required
- Proven expertise in FDA 21 CFR Part 312, ICH-GCP, and clinical trial regulations
- Strong proficiency in electronic data capture systems (e.g., Medidata Rave, Oracle Inform)
- Exceptional problem-solving skills and attention to detail in clinical documentation
- Excellent communication abilities for managing investigator relationships and regulatory agencies
- Experience with oncology or rare disease therapeutic areas highly desirable