Natera
Senior Clinical Research Associate
US Remote · Senior
Sponsorship not specified$99k-$124kDetected 1 day ago
GCPComplianceExcelHIPAAClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchCommunicationCollaborationTime ManagementWritingMicrosoft Office
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odds of building a lasting career here
50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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About the role
- 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.
- Overseeing clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
- Monitor and track clinical trial progress, provide status updates to stakeholders
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
- 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
- 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.
- Partner with other research and development groups at Natera to achieve deliverables
- Perform other duties as assigned
- This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.
- Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements
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
Skills
- Experience with clinical EDC systems,
- Familiarity with the organization and structure of the Trial Master File (TMF)
- Familiarity with bio sample management, sample processing, and biobanking best practices
- Competency in SOPs, ICH-GCP, FDA Regulations
- Proficiency in MS Word, Excel and PowerPoint
- Demonstrated ability to work independently and lead projects
- Demonstrated analytical skills and ability to identify complicated problems and propose solutions
- Strong interpersonal skills and communication skills (both written and oral)
- Excellent writing skills
- Detail oriented, with solid organization and time management skills
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Compensation
- 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.
Benefits
- Competitive Benefits - Employee 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 benefits and much more.
- Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
Company info
- Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
- We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.
Equal opportunity
- Equal Opportunity Employer.
This listing is sourced directly from Natera's careers page and normalized into a canonical job model.