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

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