Clinical Research Associate I

TL;DR

Clinical Research Associate I: Delivering quality clinical monitoring reports and ensuring clinical data validity, correctness, and completeness with an accent on ICH GCP/ISO14155 compliance, data integrity, and subject safety. Focus on planning and executing site monitoring activities (remote, on-site, or other approved mode) and managing study issues during the monitoring phase.

Location: United States of America (must be located in Arizona, California, Nevada, or Utah)

Salary: $60,000 USD annualized minimum base pay

Company

hirify.global supports biotech, medtech, and specialty pharma companies in transforming scientific ideas into new medicines, devices, and diagnostics.

What you will do

• Deliver timely, quality monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines.
• Ensure the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites per ICH GCP/ISO14155, protocol, and client requirements.
• Conduct monitoring visits (remote, on-site, or other approved mode) focused on data integrity and subject safety in line with local/regional laws and country-specific regulations.
• Plan day-to-day monitoring activities, set site priorities, and prepare for qualification, study initiation, interim monitoring, dosing observation, and close-out visits.
• Partner with the Clinical Lead (or equivalent) to proactively manage site visits and trial issues during the monitoring phase.

Requirements

• Undergraduate degree in clinical, science, or health-related field (or international equivalent), or be a licensed healthcare professional (e.g., registered nurse), or have equivalent work experience.
• Knowledge of ICH-GCP/ISO14155, FDA guidance documents, EU directives, local/regional regulations, and drug/device development and clinical monitoring procedures.
• Knowledge of clinical/health systems and cultural/professional practices relevant to the country/region where site monitoring occurs.
• Ability to multitask and work effectively with technology and people in a fast-paced environment with changing priorities; self-starter.
• Travel up to 70–85%.
• Location requirement: must be located in Arizona, California, Nevada, or Utah.

Culture & Benefits

• Comprehensive benefits package may include health insurance, retirement plans, and paid time off.
• Compensation is designed to be fair and competitive with market standards.
• Flexible work approach for monitoring (remote, on-site, or other approved mode).
• Equal opportunity employer with compliance to federal guidelines.

Hiring process

• Review of qualifications and fit for clinical monitoring responsibilities and compliance requirements.
• Interviews to assess experience with ICH GCP/ISO14155, clinical data integrity, and site monitoring execution.