Clinical Sample Management Specialist

COMPANY

Volastra Therapeutics, Inc. is a clinical-stage oncology biotech company based in New York City, pioneering novel approaches to treating cancer by targeting chromosomal instability (CIN), a unique vulnerability in cancer. Since its founding in 2019, Volastra has grown to support ongoing discovery efforts and a growing clinical organization.

Our lead pipeline programs focus on two distinct inhibitors of KIF18A, a novel therapeutic target. VLS-1488, internally discovered, entered clinical trials in Q4 2023 for the treatment of advanced cancers. Sovilnesib, in-licensed from Amgen in 2023, re-entered the clinic in Q2 2024. Both assets have been granted Fast-Track Designation by the FDA. Volastra is also developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive forward a preclinical pipeline of therapies against innovative targets.

Volastra is backed by top US and European venture firms such as Arch, Polaris, Vida, Droia, Catalio, and B Capital, alongside strategic investment from Eli Lilly. In addition to venture funding, Volastra has established partnerships with oncology leaders. Our senior leadership team is highly experienced, supported by a world-class advisory board.

We are headquartered in West Harlem, New York City, within easy reach of Columbia, Cornell, Memorial Sloan Kettering, and surrounding areas. Please visit www.volastratx.com for more information.

JOB DESCRIPTION:

The Clinical Sample Management Specialist will report to the Senior Director of Translational Science and Biomarkers and will be responsible for the oversight and supervision of clinical trial samples.

Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization. Individuals may, from time to time, have the opportunity to gain experience with projects outside their direct scope of work.

This is a remote, part-time position (~20 hours per week) with the potential to convert to full-time based on performance and business needs. This role does not involve travel.

RESPONSIBILITIES:

• Accountable for the oversight and supervision of clinical trial samples: tracking, coordination, reconciliation.
• Analyze and resolve discrepancies in sample metadata using advanced Microsoft skills.
• Collaborate with internal team and external partners (sites, CROs) to address discrepancies troubleshoot issues and ensure sample data accuracy.
• Lead logistical execution of sample processing, shipping, and timelines associated with sample testing, transfer, and analysis for study deliverables in coordination with Clinical Operations/Biomarker Lead, clinical sites, external lab vendors, and couriers. 
• Review requisition forms, lab specifications and sample labels and other controlled documents related to sample management.
• Generate sample status updates and tracking reports for internal and external use.
• Track and record any quality deviations for clinical sample handling and shipping. Actively collect, interpret, review, and document quality deviations for clinical sample handling and shipping in the appropriate system.

REQUIREMENTS:

• Bachelor’s Degree with 2+ years of experience in the pharma industry or biotech managing sample logistics.
• Advanced knowledge of Microsoft Excel for sample tracking and discrepancy resolution.
• Experience in clinical trials, clinical operations and clinical data management
• Sample Vendor Management Experience (PK/PD, tissue and imaging)
• Experience managing international logistics (e.g. customs, import/export Licenses, insurance etc.) associated with sample shipments from clinical sites to central labs and to third party labs as required.
• Strong problem-solving skills and ability to manage complex situations
• Effective verbal and written communication skills to facilitate operational excellence throughout the study lifecycle.
• Highly detail oriented and organized

Hourly Rate Range:

Approximately $25 – $30 per hour, commensurate with qualifications and experience.