About this role
Role Overview
- 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.
Requirements
- BA/BS degree in life sciences, related field, or equivalent.
- Minimum of 4 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields.
Benefits
- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Free testing for employees and their immediate families in addition to fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Generous employee referral program!