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Senior Clinical Research Associate

22 hours, 34 minutes ago
United States
Full-time
Senior
Project Manager
Project and Program Management
GCP HIPAA
Apply Now
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004
View All Jobs 65

Description

  • Provide logistical support for clinical study operations, including study start-up, site qualification, site initiation, site management, monitoring, and closeout.
  • Develop study documents such as protocols, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions.
  • Manage study contracting, budgets, invoicing, and vendor payment processes for small to medium studies.
  • Support clinical data management with case report form design, completion guidelines, EDC support, and testing.
  • Prepare, file, handle, and archive clinical documentation and reports in accordance with SOPs and study requirements.
  • Oversee clinical trial supplies for biospecimen collection, processing, shipment, storage, and tracking.
  • Train CROs, vendors, investigators, and study coordinators on study requirements and site issues.
  • Monitor clinical trial progress, track status, and provide updates to stakeholders.
  • Develop and follow monitoring plans to identify protocol deviations and data discrepancies.
  • Perform study activities such as participant consent, ethics submissions, and participant data and sample tracking when Natera operates as a clinical research site.

Requirements

  • BA/BS degree in life sciences, a related field, or equivalent experience.
  • Minimum 4 years of experience working on clinical studies in academic, biopharma, diagnostics, or medical device settings.
  • Experience with clinical EDC systems.
  • Familiarity with Trial Master File (TMF) organization and structure.
  • Familiarity with biosample management, sample processing, and biobanking best practices.
  • Knowledge of SOPs, ICH-GCP, and FDA regulations.
  • Proficiency in MS Word, Excel, and PowerPoint.
  • Ability to work independently and lead projects.
  • Strong analytical, interpersonal, written, and oral communication skills.
  • Must complete or provide current training in HIPAA/PHI privacy, Human Subjects Protection, and GCP, and maintain Natera training requirements.
  • Must pass a post-offer criminal background check.

Benefits

  • Pay range of $99,400 to $124,200 USD for Remote USA.
  • Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) benefits.
  • Commuter benefits.
  • Generous employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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