POSITION SUMMARY:

The Sr. Clinical Biospecimen Operations Associate is responsible for the execution of biosample activities for clinical research studies utilizing Natera tests, including leading coordination of operational activities for project execution, conduct, and close-out in scope with the study contracts, as applicable, and clinical study protocols. This position performs required job duties with oversight from the Clinical Trials Services (CTS) leader and will work closely with the internal and external teams, including central testing laboratories, vendors, Data Management, Product Management, Engineering and external collaborators. Activities are conducted in compliance with the study contract (as applicable), documented project requirements, study protocol(s) and plans, SOPs, and applicable regulatory requirements.

PRIMARY RESPONSIBILITIES:

● 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. that may be impacting patient testing or reporting.
● 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).
● 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

• Performs other duties as assigned

QUALIFICATIONS:

● 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

KNOWLEDGE, SKILLS, AND ABILITIES:

• Excellent project management skills, including timeline management and customer focus biospecimen management, sample processing, and biobanking best practices.
• Familiarity with the organization and structure of the Trial Master File (TMF)
• Competency in SOPs, ICH-GCP, FDA Regulations.
• Proficiency in MS Word, Excel and PowerPoint.
• Demonstrated ability to work independently in a fast-paced organization.
• Outgoing and confident demeanor.
• Demonstrated analytical skills and ability to identify problems and propose solutions.
• Detail oriented, with solid organization and time management skills.
• Develops and maintains subject matter expertise to effectively plan and fully execute assigned projects.

Physical Demands & Work Environment

● This position primarily works in an office environment. It requires frequent sitting, standing, and walking. Daily use of a computer is required. May stand for extended periods when facilitating meetings or walking in the facilities.
● The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.