Covance’s Global Specimen Solutions (GSS) business provides specialty services in the holistic specimen tracking space. GSS improves translational science in the drug discovery process through industry best practices and a uniquely powerful pipeline data management analytics solution. GSS reduces the time, cost and risk of specimen based research, while building robust, healthy data pipelines that optimize research opportunities.
The Clinical Specialist is responsible for assisting with ongoing clinical specimen operations for Global Specimen Solutions, Inc.
C. Essential Job Duties:
* Operational Execution
o Codification of Informed Consents based upon GSS' SOP
o Development and entry into GlobalCODE® of Specimen Management Plans (SMP)
o Preparation of GSS' annual update of global Regulation and Guidance documents
o Perform GSS Enhanced Monitoring functions
o Assist with the development/maintenance of GSS documentation:
* Training documents for clients using GlobalCODE® and snapTRACK® -in sync with new system releases
* Visualizations - index of visualizations, definition of Core report, listing of data elements, identification of client persona who would need specific visualizations, etc.
* Assist Quality Assurance in regulatory certifications (ISO, Data Privacy, etc), validation processes, SOP writing
* Any corporate activities assigned
3-5 years of experience in clinical trial, laboratory and/or specimen management
Central Lab project setup, informed consent and regulatory knowledge, molecular biology, specimen management, clinical pharmacogenomics or biomarker research experience are all a plus. Detail oriented, ability to work independently and ability to work/communicate effectively with clients. Excellent organization skills, ability to manage multiple tasks and projects, and meet deadlines.
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