Clinical Biospecimen Operations Associate (Life Sciences)

TL;DR

Clinical Biospecimen Operations Associate (Life Sciences): Coordinating operational activities for tracking, testing, and reporting oncology clinical trial samples with an accent on regulatory compliance and sample lifecycle management. Focus on optimizing turnaround times, maintaining eTMF documentation, and ensuring strict adherence to ICH-GCP and FDA regulations.

Location: Austin, TX

Salary: $88,200 - $110,200 USD

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health.

What you will do

• Coordinate operational activities for tracking, testing, and reporting clinical trial samples to ensure agreed upon TAT.
• Develop and maintain dashboards and KPIs to monitor metrics and trends related to sample testing.
• Manage the end-to-end lifecycle of clinical samples from receipt to result reporting and return.
• Review clinical study protocols for sample collection alignment with company policies and SOW.
• Administer clinical trial supplies for biospecimen collection, processing, shipment, and storage.
• Maintain study files in eTMF and monitor studies for protocol deviations or data discrepancies.

Requirements

• BA/BS degree in life sciences or a related field.
• Minimum of 5 years of experience working on clinical studies in biopharma, diagnostics, or medical device fields.
• Familiarity with biospecimen management, sample processing, and biobanking best practices.
• Competency in SOPs, ICH-GCP, and FDA Regulations.
• Proficiency in MS Word, Excel, and PowerPoint.
• Must be based in Austin, TX.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans for employees and dependents.
• 401k and commuter benefits.
• Free genetic testing and fertility care benefits for employees and immediate families.
• Pregnancy and baby bonding leave.
• Supportive environment working alongside industry experts in genetic disease management.