Maintain oversight of all study sample operational activities including planning, coordinating and tracking clinical trial sample testing to ensure results are provided within agreed upon TAT
Meticulously track clinical trial samples from sample receipt to result reporting to investigator sites and/or external collaborators (and sample return, if applicable)
Utilize operational and project management skills to anticipate, investigate and resolve issues to ensure deliverables and TAT are met; raise issues to Pharma Operations Team Leader
Review and provide input to clinical study protocol for sample collection
Administer clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
Organize and plan meetings and provide agenda and meeting minutes as needed
Monitor studies to identify protocol deviations or data discrepancies and issue data clarification forms, as needed
Requirements
Must maintain a current status on Natera training requirement including General Policies and Procedure Compliance and security training.
BA/BS degree in life sciences, related field, or equivalent
experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields
Familiarity with biospecimen management, sample processing, and biobanking best practices •
Experience with clinical EDC systems
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
Demonstrated analytical skills and ability to identify problems and propose solutions
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.
Detail oriented, with solid organization and time management skills The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
Austin, TX $88,200 — $110,200 USD OUR OPPORTUNITY
Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other
benefits include pregnancy and baby bonding leave, 401k benefits, commuter
Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY.
Additional details
The Clinical Biospecimen Operations Associate executes oncology clinical research studies, including coordination of all operational activities required for tracking, testing and reporting clinical trial samples.
This position will perform required job duties with oversight from the Pharma Operations Team Leader and will work closely with internal and external central testing laboratories, vendors, Data Management, Product Management, Engineering and external collaborators in compliance with the study protocol(s), SOPs, and applicable regulatory requirements. PRIMARY RESPONSIBILITIES:
Work with Data Management to develop and maintain dashboards and KPIs representing metrics and trends related clinical trial sample testing and the status of clinical studies and present to study teams and management teams, as needed.
Responsible for handling data files to support timely result reporting
requirements and alignment with the SOW, study plans and company policies
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
Partner with other research and development groups at Natera to achieve 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) in order to perform the job.
This may differ in other locations due to cost of labor considerations.