Sr. Clinical Research Associate

About the Role:

• The Sr. Clinical Research Associate manages advanced clinical site monitoring across Karius clinical programs.
• This role ensures adherence to ICH-GCP guidelines, FDA regulations, and company procedures.

Key Responsibilities:

• Independently plan and conduct on-site and remote monitoring visits including SQV, SIV, IMV, and COV.
• Apply risk-based monitoring to evaluate site performance and data quality.
• Mentor junior CRAs and oversee site-level study start-up and closeout activities.

Qualifications:

• Bachelor's degree in life sciences and 5-8 years of clinical monitoring experience.
• Strong knowledge of ICH-GCP, FDA regulations, and risk-based monitoring frameworks.
• Proficiency with EDC systems, CTMS, and eTMF platforms.

Travel Requirements:

• Travel required up to 80% of the time.
• May involve travel on short notice and managing own logistics.