Natera

Senior Clinical Biospecimen Operations Associate

Natera

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $98,600 - $123,200 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Maintain oversight of all study operational activities including supporting routine study requirements efforts to drive readiness timelines, kick-off and planning activities, study conduct management within contractual agreements, and closure activities. May contribute to all aspects (start-up to close-out) of more complex trials led by more experienced Clinical Biospecimen Operations Managers.
  • Regularly monitors the overall health of the study from study start-up through closure, including routine evaluation of key metrics (TAT, TNP), project management of key milestones and activities, and escalation of project risks and mitigation plans both internally as well as to the study sponsor when appropriate.
  • Works with Data Management and Sample Management to develop and maintain dashboards and KPIs representing metrics and trends related to clinical trial sample testing and the overall health status of clinical studies. Regularly presents trial metrics to study teams and management teams, as needed.
  • Escalation of data management and sample management issues that may be impacting patient testing or reporting and that extend beyond the established procedures to appropriate internal or study sponsor stakeholders for case resolution.
  • Utilize operational and project management skills to anticipate, investigate and resolve issues to ensure deliverables and TAT are met; raise issues to CTS leadership.
  • Review and provide input to clinical study protocol for sample collection requirements and alignment with the SOW, study plans and company policies.
  • Demonstrated ability to facilitate meetings both internally and externally, providing meeting agendas and minutes as appropriate.
  • Assist in developing study plans (e.g. Communication Plan) and departmental and study specific SOPs and work instructions with SME.
  • Assist in the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements; set up and maintain study files in eTMF (when applicable).
  • Monitor studies to identify protocol deviations or data discrepancies and issue data clarification forms, as needed.
  • Partner with other cross-functional groups at Natera to achieve study deliverables.
  • This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) to perform the job.
  • Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, human subjects protection, and GCP.
  • Performs other duties as assigned

Requirements

  • BA/BS degree in life sciences, related field, or equivalent
  • Minimum of 2-5 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields
  • Employee must pass post offer criminal background check