The opportunity
The Senior Clinical Research Associate is responsible for the overall operational execution of clinical studies on one or more clinical projects/programs; from study concept through study completion. This position will perform required job duties with guidance from Clinical…
What you'll do
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
What they're looking for
- 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.