Job Title: Accessioning Lead

Company Summary

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

Position Summary

The Accessioning Lead will be responsible for performing accessioning activities in support of research, regulated products, and clinical testing. Under the guidance of the Site Lead you will work collaboratively within the cross functional laboratory teams leveraging your technical knowledge, skill and abilities to ensure efficient processing of samples upon receipt and quality results are provided to our partners and patients through proper sample handling, documentation, and storage. The Accessioning Lead will collaborate with the Alliance Management and Clinical Operations departments to manage external communication in support of partner studies and clinical testing. This position will report to the Site Lead.

Responsibilities

• Support day to day operations by receiving samples and completing the accessioning intake process ensuring sample integrity

• Develop and implement processes and procedures to support continuous improvement of the accessioning function

• Collaborate cross functionally on LIMS development, implementation and integration as the accessioning SME

• Route samples to storage or directly to a downstream lab team member for immediate processing

• Identify and implement rejection criteria and documentation for samples following the escalation path to leadership as needed

• Maintain all required documentation to ensure chain of custody

• Collaborate with Alliance Management and Clinical Operations to support and enable external communication with partners in support of accessioning activities before, during and after study execution, to include participation in study kickoff meetings with external partners to educate on sample requirements and answer questions to enable successful outcomes for each study, reconciliation of samples received and outstanding, and return or disposal of samples per contractual obligations

• Safely handle, store, requeue, troubleshoot or discard specimens as defined by the SOP

• Appropriate handling of biohazard waste, including labeling and disposal

• Ensure regulatory compliance by following local, business, regulatory body and corporate safety policies

• Propose, and participate in process improvements for the accessioning process under guidance from the Site Lead

• Source samples to support research and regulated product development and internal studies

• Assess, scope and triage new projects/products in coordination with the Site Lead

• Develop and maintain the sample retention program and documentation to support internal research and regulated product development and studies

• Participate as a contributing member of the production laboratory by assisting in routine activities, to include but not limited to general upkeep and stocking, SOP author and review, and continuous improvement

• Attend and participate in cross functional meetings

• This role will have direct supervisory responsibilities

Quality, Training & Equipment

• Maintaining documentation in compliance with Good Laboratory Practices and Quality Systems

• Assist with quality control and quality assurance activities. Responsible for reviewing and analyzing the health of accessioning quality metrics in collaboration with the Site Lead

• Wear appropriate PPE as required and comply with safety rules and regulations

• Follow standard operating procedures (SOP)

• Maintain laboratory equipment and instrumentation in accordance with the SOP.

• Adhere to the laboratory's quality control policies including document control activities, change management, corrective preventative action

• Act as a trainer for accessioning team members

Team

• Cultivat