Senior Clinical Specimen Acquisition Specialist
United KingdomFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 2+ years
- Required Skills
- GCP
Requirements
- PhD in life sciences, health sciences, biotechnology, or a related discipline.
- 2+ years of hands-on experience in clinical specimen procurement, biospecimen logistics, and vendor or site coordination.
- Experience preparing and reviewing specimen-related documentation such as shipment records and informed consent.
- Strong knowledge of human biospecimens, including serum, plasma, FFPE, and frozen tissue.
- Understanding of specimen types, storage conditions, and quality attributes.
- Knowledge of regulatory and ethical standards including GCP, FDA 21 CFR Part 11, ICH-GCP, and IRB requirements.
- Ability to prioritize tasks, follow SOPs, and work independently in a time-sensitive environment.
- Strong organizational skills with attention to detail in tracking specimens and verifying paperwork.
Responsibilities
- Identify and coordinate specialized vendors for complex clinical specimen procurement.
- Manage documentation, track timelines, and oversee order statuses and deliveries.
- Ensure compliance with SOPs regarding specimen handling, chain of custody, and regulatory data integrity.
- Support audit readiness by maintaining accurate logs, consent documentation, and shipment records.
- Collaborate with Clinical Development teams to align specimen requirements and inclusion/exclusion criteria.
- Coordinate with Biobank/Biorepository teams to manage specimen transfer and inventory status reporting.
- Identify and suggest improvements for specimen procurement workflows and documentation practices.
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