The Opportunity:

Universal DX is seeking a Biosample Research Associate to join our growing Product Development team. This role will help manage the clinical biosample and derivative sample needs that support Signal-C development, including model training, assay development, analytical validation, and clinical validation readiness. The Biosample Research Associate will be responsible for coordinating sample selection, reservation, inventory tracking, use allocation, vendor sample procurement, and sample governance workflows so that high-value plasma and cfDNA samples are used intentionally, traceably, and in alignment with study needs.

This is an individual contributor role intended for a highly organized candidate with biospecimen operations, sample inventory, data tracking, and vendor coordination experience.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you’ll contribute:

• Manage plasma, cfDNA, and related derivative sample needs for Product Development, including samples used for model training, assay development, analytical validation, and clinical validation support.

• Use UDx sample selection and inventory tools to identify, reserve, track, and request appropriate clinical trial samples; maintain trackers for sample category, clinical annotations, volume, processing status, intended use, study assignment, and disposition.

• Partner with R&D, Assay Development, Clinical Operations, Lab Operations, Bioinformatics, Biostatistics, Quality Assurance, and Regulatory Affairs to translate study needs into sample pulls, shipment requests, manifests, and execution-ready sample lists.

• Help develop and apply sample governance rules for model training, analytical validation, clinical validation support, and other assay development uses.

• Support governance controls that prevent inappropriate overlap between training and validation sample sets, protect scarce sample categories, and preserve traceability of sample selection rationale.

• Coordinate with external biospecimen vendors to define sample requirements, review documentation, support quotes and purchase requests, coordinate shipment logistics, and reconcile received materials against manifests.

• Monitor plasma and cfDNA consumption across assay development studies; forecast sample needs, identify gaps or bottlenecks, and escalate risks early.

• Coordinate with Lab Operations for sample receipt, accessioning, storage, check-in/check-out, shipment, return-to-inventory, and reconciliation under internal procedures.

• Maintain inspection-ready records and support continuous improvement of sample management procedures, tracker tools, dashboards, templates, discrepancy resolution, and cross-functional governance workflows.

What you’ll bring:

Required Qualifications

• Bachelor’s or Master’s degree in Biology, Molecular Biology, Genetics, Biotechnology, Clinical Research, Laboratory Science, or a related life-science field.

• 2+ years of experience in biospecimen management, biorepository operations, clinical or research sample operations, translational research operations, diagnostics/IVD sample management, or a related area.

• Experience working with human biospecimens and associated metadata; experience with blood, plasma, cfDNA, or oncology-related sample types is strongly preferred.

• Strong attention to detail and documentation discipline, including experience maintaining sample inventories, reconciling manifests, tracking chain of custody, and resolving discrepancies.

• High proficiency with Excel or similar tracking tools; ability to maintain clean datasets, use filters/lookups/pivots, and identify data inconsistencies across trackers or manifests.

• Comfort working with sample-management systems, LIMS/inventory tools, controlled trackers, or web-based sample selection tools.

• Ability to interpret sample eligibility and selection constraints based on study purpose, clinical annotations, availability, volume, processing status, and downstream use requirements.

• Experience coordinating with internal stakeholders and external vendors to meet timelines and keep sample requests moving.

• Working awareness of regulated laboratory, biorepository, or QMS expectations; excellent organizational, written, and verbal communication skills.

Preferred Qualifications

• Experience supporting sample logistics for development, validation, or regulated laboratory studies.

• Experience with cfDNA, liquid biopsy, NGS, methylation-based assays, oncology, or cancer screening studies.

• Experience using LIMS/inventory systems, EDC systems, SharePoint, Smartsheet, or similar controlled tracking platforms.

• Experience procuring clinically annotated biospecimens from external vendors and reviewing sample documentation, manifests, certificates of analysis, or vendor data files.

• Experience supporting analytical validation, model training sample sets, clinical validation studies, or regulated IVD development programs.

• Basic familiarity with sample randomization, batching, reagent lot balancing, run planning, or plate/sample list generation.

What we´ll offer:

We’re proud to offer exceptional corporate benefits which include:

• 22 days of PTO with the possibility to carry over 10 days to the following year.

• Company Holidays, plus your Birthday off!

• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).

• Flexible work schedule

• And more to come!