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Research Associate, Translational Biology III

South San Francisco, CA 94080

Posted: 01/23/2023 Employment Type: Contract Job Category: Scientific Job Number: 541261 Is job remote?: No Country: United States

Job Description


The Role:
Pay rate range: $40-46/hr


Seeking a Biomarker Operations, Sr. Specialist/Sr. Research Associate to support the translational biology teams and to work across its clinical trials as well as with external biorepositories, assay laboratories and CROs. This position will work collaboratively Sickle Cell Disease area teams to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted.

Here’s What You’ll Do:
  • Provide logistical support for implementation of clinical biomarker sample management plans in clinical trials
  • Draft and review of biomarker sections of clinical protocols, lab manuals
  • Willing to working on bench to lead clinical sample assay/kit development.
  • Track and manage processes throughout clinical sample lifecycle and biorepository usage
  • Ensure standardized language for sample information and standardized processes sample reconciliation
  • Support clinical teams to ensure biosamples are compliant with informed consent and GCP/ICH, if applicable
  • Oversee clinical assay vendors (routine sample analysis meetings, address sample issues, sample shipments)
  • Track ongoing biospecimen quality issues at global central labs and 3rd-party vendors
  • Works closely with data management lead and clinical science lead to ensure the biomarker data will be captured, blinded and transferred for clinical trials properly
  • Enables transfer of biomarker/exploratory data from vendor through development and review of an appropriate data transfer specification and related documents and evaluates data integrity
  • This job may require 10-15% of time within US and international travel, occasionally night time or weekend hours to fulfill clinical request, if applicable

 

Here’s What You’ll Bring to the Table:
 
  • Bachelor’s degree in a life science-based subject; advanced degree preferred
  • Minimum of 3 years of experience in related role within clinical development at a Pharmaceutical, Biotechnology company, laboratory or CRO. Working knowledge of clinical trials, clinical laboratory processes & systems, clinical databases is preferred.
  • Knowledge and practice using efficiency, collaboration and operations management applications and collaboration tools (e.g. Microsoft Word, Excel, Powerpoint, Teams, Smartsheet).
  • Possess excellent communication skills, with the ability to communicate across a matrix environment in real time. Handles a high-paced and invigorating environment, adapts quickly, drives change, is passionate about patients and science and exemplify teamwork
  • Ability to handle and resolve problems on the fly as well as strong project management and organizational skills
  • Strong interpersonal skills and ability to work with many different groups/teams to achieve success

Preferred:
  • Direct experience with clinical sample management
  • Prior process development experience is very helpful
  • Familiarity with databases is helpful
  • Strong communication skills and attention to detail
  • Demonstrated ability to multitask
  • This position is open to remote with travel to South San Francisco, with short notice (1-2 weeks). However, preference will be given to local candidate.
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