Biomarker Sample Operations Associate III

Planet Pharma; North Chicago (IL); Sur place; USD 50 000 - 71 000; Plein temps

Résumé du poste

Planet Pharma is seeking a Biomarker Sample Operations Associate to manage receipt, accessioning and tracking of clinical trial biomarker specimens. You will work closely with operations managers and lab staff to ensure timely processing, labeling and storage in StarLIMS, while maintaining compliance with protocols and regulatory requirements.

Responsibilities include coordinating sample processing and data transfer, maintaining storage equipment and partnering with vendors to ensure on-time

Qualifications

• Master’s or Bachelor's degree with several years in project management and oncology/biomarkers context.
• Experience in clinical trials and biomarker studies is required or highly preferred.
• Strong communication and organizational skills with ability to work with minimal supervision.

Responsabilités

• Oversee receipt, accessioning and tracking of biomarker samples using StarLIMS.
• Coordinate sample processing, labeling, storage and data transfer to labs.
• Maintain storage equipment and monitor temperature and compliance with protocols.
• Collaborate with vendors and project teams to ensure timely shipments and data reconciliation.
• Assist with development and management of sample-tracking systems and continuous improvement.

Connaissances

Project management

Communication

Attention to detail

Time management

Analytical skills

Interpersonal skills

Independent work

Formation

Master’s degree in a related field

Bachelor’s degree in a related field

Outils

StarLIMS

MS Office

Description du poste

Target PR Range: 24-34/hr
*Depending on experience

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials. The Biomarker Sample Operations Associate works closely with operations managers, project managers and laboratory managersto ensure timely and smooth receipt, transfer and testing of clinical trial biomarker specimens in compliance with protocols, regulatory requirements and project timelines. This role is responsible for accessioning and tracking samples in StarLIMS, including labelling, shipping and storage. This role will with work together with laboratory managers and biomarkerstudy management teams to complete tasks. This role will drive innovation and continuous improvement activities in bio-sample collection, processing and transfers, and demonstrate ability to carry out all bio-sample operations with minimal supervision.

Responsibilities

• Responsible for receipt and tracking of incoming sample shipments, sample accessioning and tracking samples throughout their lifecycle using StarLIMS.
• Coordinate sample processing, labelling, and storage
• Maintain sample storage equipment (Refrigerator/Ultralow/LN2) and monitor equipment functionality and temperature
• Coordinate sample analysis and data transfer. Pull sample inventory reports from various databases and determine the accurate list of samples available for testing.
• Plan, organize and ship biomarker samples from investigator sites or centralized locations and subsequent delivery to assay laboratories orsites. Ensure timely shipments to vendors and/or storage sites.
• Manage relationships with laboratory vendors, provide input into trial-specific documents and assess service level commitments of labs involved in sample analysis. Ensure issues are resolved or escalated in a timely manner.
• Help project managers with vendor oversight in compliance withprocedures and applicable regulations.
• In partnership with Clinical Operations, Biomarker Scientists, and IT, contribute to the development, implementation, and management of a sample tracking system for assigned studies.
• Contribute to functional process and system improvements to ensure samples are collected, processed, analyzed, transported, stored, and destroyed appropriately for each assigned study.
• Reconcile data and samples stored in databases.
• Adhere to ICH/GCP, biorepository procedures, biosample management best practices and ethical guidelines.
• Contribute to a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels.
• Balance multiple priorities in a fast-paced, team-based environment and work independently when needed.

Qualifications

• Master’s Degree with 3+ years project management, knowledge of oncology, including biomarkers and/or clinical trial experience
• Bachelor’s Degree with 4+ years of project management, knowledge of oncology, including biomarkers and/or clinical trial experience
• Expertise in MS Office applications including Excel, Word and PowerPoint
• Excellent oral and written communication skills in English
• Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills
• PMP certification a plus
• Clinical trial experience
• Scientific background and knowledge of oncology
• Ability to work with minor supervision