Biomarker Sample Operations Associate III

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 or sites. 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 with procedures 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