Job Description
Join NovoMed Therapeutics, a leader in groundbreaking biopharmaceutical innovation, as we pioneer next-generation therapies for rare diseases. We're seeking a meticulous Clinical Research Associate to oversee critical clinical trials ensuring regulatory compliance and data integrity. This role offers unparalleled exposure to cutting-edge research methodologies and the opportunity to directly impact patient lives.
Responsibilities
- Monitor clinical trial sites for protocol adherence and regulatory compliance (FDA/ICH-GCP)
- Conduct site visits, source document verification, and data quality audits
- Collaborate with investigators to resolve protocol deviations and ensure patient safety
- Prepare comprehensive study reports and regulatory submissions
- Coordinate with CROs and internal teams to maintain trial timelines
- Manage trial documentation and electronic data capture systems
- Analyze adverse events and ensure proper safety reporting protocols
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 2+ years of clinical research experience with Phase II-III trials
- CRA certification (ACRP or SoCRA) required
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of FDA regulations and GCP principles
- Exceptional attention to detail and documentation skills
- Ability to travel 40-50% domestically and internationally
- Excellent communication and problem-solving abilities