Clinical Research Associate II (Clinical Research)

TL;DR

Clinical Research Associate II (Clinical Research): Managing and monitoring clinical research study sites with an accent on patient safety and data integrity. Focus on conducting site visits, overseeing regulatory compliance, and ensuring adherence to ICH-GCP standards.

Location: Remote, but must be based in Texas or California

Salary: $91,500 - $137,300 USD

Company

hirify.global is a professional services provider specializing in clinical research monitoring and site management for the pharmaceutical and biotech industries.

What you will do

• Oversee all aspects of study site management to ensure patient safety and high-quality data generation.
• Conduct all forms of site visits, including qualification, initiation, routine monitoring, and close-out visits.
• Manage site start-up procedures, including feasibility, recruitment of investigators, and regulatory submissions.
• Verify informed consent processes and assess factors affecting subject safety and data integrity.
• Perform investigational product (IP) inventory reconciliation and review storage and security.
• Collaborate with project management to resolve protocol issues and implement necessary corrective actions.

Requirements

• 4-year college degree or equivalent in a scientific or healthcare discipline.
• Minimum 2 years of experience as a CRA in a CRO, pharmaceutical, or biotech environment.
• Experience monitoring oncology trials.
• Ability to travel overnight up to 60% on average.
• Must be living in Texas or California.
• Fluency in English.

Nice to have

• Graduate or postgraduate degree.
• Auto-immune monitoring experience.
• Experience monitoring in rare and complex therapeutic areas.
• Experience monitoring EDC trials and EHR records.

Culture & Benefits

• Discretionary annual bonus.
• Comprehensive health, life, and disability insurance.
• Retirement savings benefits.
• Paid time off for vacation and sick leave.
• Parental leave.