POSITION SUMMARY:

The Clinical Research Associate helps design and execute clinical research studies focused on the development and validation of cancer detection tests. This role will Wwork closely with Natera’s clinical trials, medical education, and scientific communications teams to accomplish this end.

PRIMARY RESPONSIBILITIES:

• Work closely with the study lead to 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
• Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC
• 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 to ensure protocol compliance and overall data accuracy
• 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
• Day to day tasks are discussed with manager (increasingly independent)
• May suggest process improvements to manager to be considered as development opportunities
• This role works with PHI on a regular basis both in paper and electronic form and utilizes various technologies to access PHI (paper and electronic) in order to perform the job.
• 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
• Performs other duties as assigned

QUALIFICATIONS:

• BA/BS degree in life sciences, related field, or equivalent
• Minimum of 2 years of experience with clinical trial monitoring of investigative sites
• Oncology clinical trial experience is highly desired

KNOWLEDGE, SKILLS, AND ABILITIES:

● 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, FDA Regulations
● 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