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Natera · 9 hours ago

Sr Clinical Research Associate

United States

Full-time

Remote

Mid, Senior Level

$99K/yr - $124K/yr

4+ years exp

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The Senior Clinical Research Associate is responsible for the overall operational execution of clinical studies, ensuring compliance with protocols and regulatory requirements while managing study logistics and documentation.

BiotechnologyGeneticsHealth DiagnosticsMedicalWomen's

Responsibilities

Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations

Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required

Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight

Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC

Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements

Overseeing clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information

Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues

Monitor and track clinical trial progress, provide status updates to stakeholders

Develop new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies

Perform study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies where Natera functions as a Clinical Research Site

Update Clinical Department SOPs with guidance from CTM and/or Director

Partner with other research and development groups at Natera to achieve deliverables

Perform other duties as assigned

Qualification

Clinical EDC systemsSOPsICH-GCPFDA RegulationsBio sample managementTrial Master File (TMF)MS WordExcelPowerPointAnalytical skillsInterpersonal skillsCommunication skillsDetail orientedTime management skills