Senior CRA II: West Coast Monitoring Lead

Mykelly; Denver (CO); On-site; USD 80,000 - 89,000; Full time

Job summary

Mykelly is seeking a Sr Clinical Research Associate II to support regional studies on a six‑month project with potential extension. The role requires monitoring complex therapeutic studies, independent work, and travel up to 80% across the West Coast.

You will coordinate remote and on‑site visits, ensuring protocol compliance and high data quality. Ideal candidates have CRO monitoring experience and a strong understanding of ICH‑GCP guidelines, with a track record of site management and

Qualifications

• Bachelor’s degree in life sciences required.
• 3+ years on-site monitoring experience.
• Experience with large CRO monitoring.
• CRA contracting experience preferred.
• Valid driver’s license required.

Responsibilities

• Monitors investigator sites using risk-based monitoring approaches and prepares action plans.
• Ensures data integrity through SDR/SDV review and CRF checks during visits.
• Manages investigational products through inventory checks and records reviews.
• Documents observations in reports and follow-up letters in a timely manner.
• Escalates issues to clinical management and ensures timely resolution.
• Maintains regular site communication to ensure compliance and data entry.

Tools

MS Office

EDC

CTMS

Job description

Mykelly is seeking a Sr Clinical Research Associate II to support regional studies on a six‑month project with potential extension. The role requires monitoring complex therapeutic studies, independent work, and travel up to 80% across the West Coast.

You will coordinate remote and on‑site visits, ensuring protocol compliance and high data quality. Ideal candidates have CRO monitoring experience and a strong understanding of ICH‑GCP guidelines, with a track record of site management and