CRA - IVD Clinical Monitoring & Lab Oversight

BioPhase; San Francisco (CA); On-site; USD 61,992 - 75,768; Full time

Benefits offered by this job

Competitive hourly contract rate

Possibility of extension

Supportive work environment

Work-life balance flexibility

Job summary

A biotech research firm in San Francisco is seeking an experienced Clinical Research Associate on a contract basis for a minimum of 6 months. This role emphasizes laboratory oversight and regulatory compliance in IVD studies, managing monitoring activities, and collaborating with sponsors. Ideal candidates will have 3 to 5 years of CRA experience and a strong understanding of 21 CFR regulations. This position offers a competitive hourly rate with the potential for extension or transition to longer-term employment.

Qualifications

• 3–5+ years of experience as a CRA in IVD trials.
• Solid understanding of 21 CFR Part 812.
• Hands-on experience in lab-based clinical trials.

Responsibilities

• Conduct comprehensive site monitoring across all trial phases.
• Perform monitoring of laboratory activities.
• Partner with external sponsors to align project milestones.
• Oversee lab‑related operations and resolve issues.
• Prepare and review monitoring documentation and reports.

Skills

Site monitoring

Laboratory oversight

Collaboration with sponsors

Regulatory compliance

Problem-solving

Organizational skills

Communication skills

Education

Bachelor’s degree in life sciences

Tools

CTMS/EDC systems

Job description

A biotech research firm in San Francisco is seeking an experienced Clinical Research Associate on a contract basis for a minimum of 6 months. This role emphasizes laboratory oversight and regulatory compliance in IVD studies, managing monitoring activities, and collaborating with sponsors. Ideal candidates will have 3 to 5 years of CRA experience and a strong understanding of 21 CFR regulations. This position offers a competitive hourly rate with the potential for extension or transition to longer-term employment.