Clinical Biomarker Specimen Specialist

The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager, Study Managers, and Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody is maintained through the specimen lifecycle from collection through testing and final sample disposition. This role requires clinical study, specimen management, and project management experience. As well as knowledge of GxP, and vendor-sponsor best practices.
Principal Responsibilities
Clinical specimen management from collection through testing and final disposition.
Ensures compliance with Clinical Protocol and Informed Consent
Maintain chain of custody
Organize and oversee the collection, shipping and proper storage and maintenance of
clinical specimens.
Resolve and/or triage specimen queries from sites or vendors.
Ensuring proper documentation of specimen destructions are obtained and filed
appropriately.
Collaborate on implementation and maintenance of specimen tracking system
Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical
Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to
ensure proper alignment and study-level execution of specimen management.
Required Qualifications
Years of experience: 2-5 years; dependent on level of related skills and education
Laboratory background and/or strong knowledge of commonly tested biomarkers in the
oncology setting, latest and advanced analytical tools and assays
Effective project management and time management skills; able to prioritize successfully
Proficiency with data sets and Excel, understanding of data relationships and metadata
Confident in overseeing vendors and communicating with experts to drive quality
deliverables
Technologically savvy; quickly picks-up on new information, standards, regulations, tools,
methods or software as it relates to position and profession
Detail oriented; performs quality and accurate work with minimal oversight
Excellent written/verbal communication skills
Can identify opportunities for efficiency improvements and simplification, recognizes
appropriate
Resources for deliverables, has effective organizational skills
Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds
constructive and effective relationships, is approachable, communicates effectively
Flexible, easily adapts to change, and is energized by challenges and problem-solving
Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style
to existing process as appropriate
Preferred
Previous biobanking, sample tracking and handling experience
Previous LIMS (Laboratory Information Management System) experience
Working knowledge of the clinical drug development process
Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database
development and UAT
Oncology experience and/or working knowledge
Proficiency with timeline management
Education
BA/BS in relevant field; years of experience may substitute for education

Skills
GCP, Excel, Project Management, Documentation

Experience
2-5 yrs

Work arrangement
Yes