Sr. Clinical Research Associate (Fully Remote)

Karius; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Karius is seeking a Sr. Clinical Research Associate to manage advanced clinical site monitoring across its clinical programs.

You will ensure adherence to ICH-GCP, FDA regulations, and company procedures. You will independently plan and conduct on-site and remote monitoring visits (SQV, SIV, IMV, COV), apply risk-based monitoring to assess site performance and data quality, and mentor junior CRAs while overseeing start-up and closeout activities.

Qualifications

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

Responsibilities

• 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.

Skills

ICH-GCP

FDA regulations

Risk-based monitoring

Mentoring

On-site monitoring

Remote monitoring

EDC

CTMS

eTMF

Education

Bachelor's degree in life sciences

Tools

EDC systems

CTMS

eTMF platforms

Job description

• 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.

Karius is a clinical metagenomics company using genomics and AI to improve infectious disease diagnosis. It is a venture-backed startup with a mission-driven culture focused on advancing diagnostic science.