Job description

Duration: 02+ years Schedule: 100% onsite Purpose: • 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 managers to 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 work together with laboratory managers and biomarker study 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 or client 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 client 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 About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com . Equal Employment Opportunity (EEO): US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring. IND01 #LI-AS140

Requirements

Must-haves

Duration: 02+ years
Schedule: 100% onsite
The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials.
This role is responsible for accessioning and tracking samples in StarLIMS, including labelling, shipping, and storage.
This role will work together with laboratory managers and biomarker study 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.
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 client sites. Ensure timely shipments to vendors and/or storage sites.
Help project managers with vendor oversight in compliance with client 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.
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

Nice-to-haves

PMP certification a plus

Application prep

Use the role’s language and application details while tailoring your materials.

Keywords to mirror

gcpai

Platform: jobdiva
Effort: medium

Benefits

Benefits detected in the listing.

Vision