Clinical Biomarker Specimen Specialist
Parexel
Summary
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.
Job description
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
Requirements
- 2-5 years of experience; 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 new information, standards, regulations, tools, methods or software
- Detail oriented; performs quality and accurate work with minimal oversight
- Excellent written/verbal communication skills
- Can identify opportunities for efficiency improvements and simplification
- Effective organizational skills
- Interpersonal skills; encourages collaboration, is a team player and is cooperative
- 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
- BA/BS in relevant field; years of experience may substitute for education
Company overview
Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.