Job Description
Join NovoMed Pharmaceuticals, a global leader in innovative therapies, as we pioneer the next generation of treatments. We're seeking a dedicated Senior Clinical Research Associate to oversee critical clinical trials from protocol design to final reporting. This role offers the opportunity to work with cutting-edge therapies while ensuring compliance with global regulatory standards. Enjoy competitive benefits, professional development opportunities, and a collaborative environment where your expertise directly impacts patient lives.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials ensuring GCP/ICH compliance
- Manage relationships with investigative sites, CROs, and regulatory authorities
- Oversee site selection, initiation, and close-out activities across North America
- Analyze clinical trial data and prepare comprehensive study reports for FDA submissions
- Develop and maintain risk-based monitoring strategies and SOP documentation
- Lead cross-functional teams to resolve protocol deviations and data discrepancies
- Represent NovoMed at regulatory inspections and audits
Qualifications
- Master's degree in Pharmacy, Nursing, Life Sciences, or related field (PhD preferred)
- 5+ years of clinical research experience with at least 2 years in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Deep knowledge of ICH-GCP, FDA regulations, and clinical trial methodologies
- Proven experience managing Phase II-III oncology or rare disease trials
- Exceptional data management and auditing skills with EDC systems (e.g., Medidata Rave)
- Strong written communication skills with experience preparing regulatory documents
- Ability to travel 30-40% domestically and internationally