Clinical Research Associate, Sponsor Dedicated
Company: Northshore Home Health Care
- Location: Breckenridge, United States
- Employment type: Full-time
- Posted: 9 days ago
- Offer language: English
Job description
The Clinical Research Associate supports sponsor-dedicated monitoring activities across multiple sites, ensuring
protocol compliance, data integrity, and regulatory documentation in line with GCP and ICH standards.
Responsibilities
- Conduct site monitoring visits, including initiation, ongoing, and close-out activities according to protocol and GCP guidelines
- Develop and monitor subject recruitment plans to achieve enrollment targets
- Provide protocol training and maintain regular communication with sites to manage expectations and resolve issues
- Monitor study data quality, protocol adherence, and regulatory compliance; escalate concerns as needed
- Track study progress related to regulatory submissions, enrollment, CRF completion, and data queries
Qualifications & Skills
- Bachelor’s degree in a scientific or healthcare discipline preferred
- Minimum of 2 years of independent on-site monitoring experience as a CRA
- Strong knowledge of GCP and ICH requirements
- Proficiency with EDC, CTMS, eTMF, IVRS/IWRS systems
- Advanced skills in Microsoft Office suite
- Excellent written and verbal communication in English
- Strong organizational, problem-solving, and time management skills
