Clinical Research Associate

Summary

Join Natera as a Clinical Research Associate to design and execute clinical research studies, collaborating with various teams. Coordinate all aspects of clinical studies, prepare related documents, manage study contracting and budgeting, track samples and participant data, monitor study progress, and provide status updates. Train CROs and investigators, monitor studies, and occasionally educate participants. Partner with other research groups, review data, and prepare reports. This role involves working with protected health information (PHI) and requires adherence to HIPAA/PHI privacy, Human Subjects Protection, GCP, and other compliance training. The position requires a BA/BS in life sciences or a related field and at least two years of experience in clinical research coordination or sample management.

Requirements

• BA/BS degree in life sciences, related field, or equivalent
• Minimum of 2 years of experience in clinical research coordination and/or sample management
• Familiarity with biospecimen management, sample processing, and biobanking best practices
• Experience with clinical EDC systems
• Familiarity with the organization and structure of the Trial Master File (TMF)
• Competency in SOPs, ICH-GCP
• Proficiency in Google Workspace (gSuite), MS Word, Excel and PowerPoint
• Demonstrated ability to work independently
• Outgoing and confident demeanor
• Demonstrated analytical skills and ability to identify problems and propose solutions
• Detail oriented, with solid organization and time management skills
• Employee must complete training or provide training records relating to HIPAA/PHI privacy, Humans Subjects Protection, GCP, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
• Employee must complete training or provide training records relating to HIPAA/PHI privacy, Humans Subjects Protection, GCP, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
• Must maintain a current status on Natera training requirements

Responsibilities

• Coordinate all aspects of a clinical study
• Prepare and develop project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, IRB study protocols and amendments, and clinical summaries, as required
• Assist with managing study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites
• Track and manage clinical trial samples, including workflow design, inventory, and troubleshooting within sample management systems
• Track participant data using in-house and CRO databases, and ensure that CRF data queries are resolved
• Monitor and track clinical trial progress, provide status update reports, and manage project timelines
• May train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Monitor studies following study monitoring plans
• Occasionally educate and consent participants for research studies
• Partner with other research and development groups at Natera to achieve deliverables
• Coordinate review of data listings and preparation of interim/final clinical study reports
• Provides operational and logistical support for one or more clinical trials/studies or initiative projects
• Works on problems of moderate scope and complexity - Seeks guidance from manager and more senior peers as needed to determine the appropriate course of action
• Builds solid working relationships within the Clinical Trial Operations organization
• Contacts are internal to the company, but may interact with vendors/suppliers or clinical sites for routine requests
• Demonstrates willingness to expand personal knowledge and commitment to own development
• May suggest process improvements to manager to be considered as development opportunities
• Performs other duties as assigned

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
• We also offer a generous employee referral program!