Senior Clinical Research Associate

About the role

This role is responsible for managing the operational aspects of clinical studies from initiation to completion. You will ensure studies adhere to protocols, regulations, and internal standards, contributing to the successful execution of research projects.

Key facts

What you'll do

• Provide logistical support for clinical study operations, including site setup, supply management, and study close-out activities.
• Draft study documents such as protocols, informed consent forms, and monitoring plans with minimal supervision.
• Oversee study budgets, vendor contracts, and payment processes for clinical trial vendors and investigative sites.
• Assist the data management team with case report form design and electronic data capture (EDC) system support.
• Manage the organization, filing, and archiving of clinical study documentation.
• Coordinate the handling and tracking of clinical trial supplies, including biospecimens.
• Train external partners and site staff on study requirements.
• Track study progress and provide regular updates to stakeholders.
• Develop and implement study monitoring plans, identifying and addressing protocol deviations.
• Conduct study activities, including participant consent and ethics board submissions, when Natera acts as a research site.
• Contribute to the update of Clinical Department Standard Operating Procedures (SOPs).
• Collaborate with other Natera research and development teams to meet project goals.

Requirements

• Bachelor's degree in life sciences, a related field, or equivalent experience.
• A minimum of 4 years of experience managing clinical studies in the biopharmaceutical, diagnostics, or medical device sectors.

Nice to have

• Experience with clinical EDC systems.
• Familiarity with Trial Master File (TMF) organization.
• Knowledge of biosample management, processing, and biobanking best practices.
• Proficiency in SOPs, ICH-GCP, and FDA Regulations.
• Strong skills in MS Word, Excel, and PowerPoint.
• Proven ability to work independently and lead projects.
• Demonstrated analytical problem-solving abilities.
• Excellent interpersonal, written, and oral communication skills.
• Meticulous attention to detail, with strong organizational and time management capabilities.

Skills & tools

• Clinical EDC systems
• Trial Master File (TMF)
• Biosample management
• ICH-GCP
• FDA Regulations
• MS Word
• MS Excel
• MS PowerPoint

Practical notes

• Salary range: $99,400 - $124,200 USD. Actual compensation will be determined by factors such as experience, skills, and location.
• Comprehensive benefits package includes medical, dental, vision, life, and disability plans.
• Employees and immediate families receive free testing and fertility care benefits.
• Additional benefits include pregnancy and baby bonding leave, 401k, and commuter benefits.
• Must provide records of current training or complete training related to HIPAA/PHI privacy, Human Subjects Protection, and GCP.
• Must maintain current status on Natera training requirements.
• Must pass a post-offer criminal background check.