Senior Clinical Specimen Acquisition Specialist - Job DescriptionThe Senior Clinical Specimen Acquisition Specialist is responsible for efficient clinical specimen procurement by coordinating specialized vendors and ensuring specimens meet study requirements, quality standards, and delivery timelines through rigorous documentation practices, cross-functional collaboration, and continuous improvement of specimen procurement processes.
This position reports to the Senior Manager Global Clinical Procurement and is part of Danaher Diagnostic's Clinical Center of Excellence (CCOE) organization and will be fully remote.
In this role, you will have the opportunity to:- Procurement of Clinical Specimens: Identify and coordinate specimen vendors for clinical Specimen procurement, aligning their capabilities with study requirements. Manage all necessary documentation, track timelines, order statuses, and deliveries, while maintaining comprehensive records of communications and shipments.
- Compliance & Documentation Support: Follow SOPs related to Specimen handling, chain of custody, and data integrity to ensure full compliance with applicable regulatory requirements (e.g., FDA, IRB policies). Ensure Specimen documentation is complete, properly labeled, and aligned with procurement or collection protocols. Support audit readiness through accurate filing of logs, consent documentation, shipment records, and system-generated reports.
- Cross-Functional Collaboration: Work closely with Clinical Development teams to align specimen inclusion and exclusion criteria, data needed and other specimen requirements. Will coordinate with the Biobank/Biorepository teams for timelines and ensure smooth transfer of Specimens. Participate in cross-functional meetings and contribute to Specimen tracking updates and inventory status reports. Help resolve day-to-day issues related to Specimen documentation, storage capacity, or vendor coordination.
- Contribute to Process Improvements: Share observations and suggestions for improving workflows and documentation related to prospective Specimen collection. Participate in team discussions focused on optimizing Specimen procurement practices across studies.
The essential requirements of the job include:- Bachelor's degree in Life Sciences, Biotechnology, Biomedical Sciences, Public Health, or related field
- 2+ years of experience in biospecimen procurement, clinical research coordination, specimen logistics, or biorepository operations.
- Experience working with clinical sites, specimen vendors, biobanks, CROs, or academic institutions.
- Experience with specimen tracking, chain of custody, sample accessioning, and inventory management systems.
- Understanding of biospecimen types, storage requirements, and quality considerations.
It would be a plus if you also possess previous experience in:- Working knowledge of GCP, FDA, ICH-GCP, IRB, and related regulatory requirements.
- Strong organizational and documentation skills, with attention to detail in tracking Specimens and verifying paperwork.
- The ability to prioritize tasks, follow SOPs, and work independently in a time-sensitive, regulated environment.
It would be a plus if you also possess previous experience in:- Knowledge of regulatory and ethical standards related to clinical Specimen handling, such as GCP, FDA 21 CFR Part 11, ICH-GCP, and IRB/ethics requirements.
- Strong organizational and documentation skills, with attention to detail in tracking Specimens and verifying paperwork.
- The ability to prioritize tasks, follow SOPs, and work independently in a time-sensitive, regulated environment.
Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $120,000 - $130,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
