Natera

Sr. Clinical Biospecimens Operations Associate

United States

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Clinical Trials, HealthcareIndustries

Requirements

The Sr. Clinical Biospecimen Operations Associate must have experience in executing biosample activities for clinical research studies, including leading coordination of operational activities for project execution, conduct, and close-out. They should be able to work closely with internal and external teams, including central testing laboratories, vendors, Data Management, Product Management, Engineering, and external collaborators. The role requires an understanding of compliance with study contracts, documented project requirements, study protocols and plans, SOPs, and applicable regulatory requirements. Experience in developing and maintaining dashboards and KPIs, presenting trial metrics, and facilitating meetings is necessary. Familiarity with clinical study protocols for sample collection requirements, SOW, study plans, and company policies is expected. The ability to prepare, handle, file, and archive clinical documentation and reports, set up and maintain study files in eTMF, monitor studies for deviations, and partner with cross-functional groups is required. Access to and handling of PHI is a regular part of the role, necessitating current training in HIPAA/PHI privacy, human subjects protection, and GCP.

Responsibilities

The Sr. Clinical Biospecimen Operations Associate is responsible for maintaining oversight of all study operational activities, from start-up through closure, including routine study requirements, readiness timelines, kick-off and planning, study conduct management within contractual agreements, and closure activities. They will regularly monitor the overall health of the study, evaluate key metrics, manage project milestones, and escalate project risks and mitigation plans. This role involves working with Data Management and Sample Management to develop and maintain dashboards and KPIs, and presenting trial metrics to study teams and management. The associate will escalate data management and sample management issues that impact patient testing or reporting, and utilize operational and project management skills to anticipate, investigate, and resolve issues to ensure deliverables and TAT are met. They will review and provide input to clinical study protocols for sample collection requirements, assist in developing study plans and SOPs, and assist in the preparation, handling, filing, and archiving of clinical documentation and reports. The associate will monitor studies for protocol deviations or data discrepancies and issue data clarification forms as needed, and partner with other cross-functional groups to achieve study deliverables. They will also perform other duties as assigned.

Skills

Biospecimen Operations
Clinical Research
Project Management
Data Management
Sample Management
Regulatory Requirements
SOPs
KPIs
Metrics
Risk Management
Vendor Management

Natera

Genetic testing and diagnostics solutions provider

About Natera

Natera focuses on genetic testing and diagnostics, providing advanced solutions for cancer patients, transplant patients, and individuals assessing hereditary health risks. Their main technology is cell-free DNA (cfDNA) testing, which analyzes DNA fragments in the blood to detect minimal traces of cancer and assess organ health. Natera stands out by offering specialized tests like the Signatera ctDNA test and Panorama NIPT, along with genetic counseling services. The company's goal is to improve patient care and health outcomes through accurate genetic testing.

Austin, TexasHeadquarters
2004Year Founded
$149.9MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees

Benefits

Flexible medical plans
Investment options
Time off
Workplace perks

Risks

Hindenburg report accuses Natera of deceptive sales practices, risking legal challenges.
New Prospera Heart features may face slow adoption by healthcare providers.
Fetal RhD NIPT demand may drop post-RhIg shortage, affecting future sales.

Differentiation

Natera's Signatera test offers personalized ctDNA analysis for cancer patients.
Prospera Heart test uses unique Donor Quantity Score for transplant rejection detection.
Panorama NIPT test is a leader in non-invasive prenatal testing with 2 million tests.

Upsides

Increased adoption of liquid biopsy techniques boosts demand for Natera's cfDNA tests.
AI integration enhances accuracy and speed of Natera's cfDNA analysis.
Growing personalized medicine trend aligns with Natera's customized genetic tests.

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