San Rafael, CA
Biospecimen Management Specialist I
Biospecimen Management Specialist I
Location: San Rafael, CA (Hybrid 2 Days on site/Flexible)
Assignment: 12 months (Great potential to extend or convert)
Pay Rate: $45.30/Hr.
Summary:
Our pharmaceutical client, a global leader in therapeutics for rare and life-threatening genetic diseases, is seeking a Biospecimen Management Specialist I to support the accurate preparation of biospecimen manifests for outgoing shipments for analysis requests.
Duties:
- Serve as Client for one program or select studies across multiple programs as necessary.
- Perform continuous tracking of clinical trial collected biospecimens and related logistics.
- Support biospecimen tracking and reconciliation activities in company's in-house clinical biospecimen inventory tracking IT system.
- Review and understand Central lab and Specialty lab documentation.
- Input and maintain biospecimen-relevant information in CLBM systems.
- Respond to queries from biorepository upon receipt of samples.
- Assist in performing super user tasks in updating CBMS: Labmatrix.
- Collaborate with Central and Specialty Laboratories including long term biorepository vendor.
- Maintain accurate biospecimen inventory within central biospecimen database.
- Ensure sample integrity and maintain GCP/GLP for samples.
- Accurately follow department SOPs related to Biospecimen Management.
- Assist in fulfilling biospecimen analysis requests and facilitate returns.
- Prepare accurate biospecimen manifests for outgoing shipments.
- Track sample analysis and data transfer deliverables.
- Upload biospecimen related documents to the Trial Master File.
Requirements:
- Bachelor's degree in biology, medical technology, or related field or equivalent and 2 years of relevant experience in the pharmaceutical industry or related field.
- Working knowledge of human biospecimen sample types.
- Experience in Microsoft Office Products and Sample tracking/LIMS.
- Understand ICH/GCP/GLP, storage procedures, and ethical guidelines.