Clinical Research Associate

At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. Our technology rapidly identifies bacterial infections and predicts the most effective antibiotics to treat the infection. We’re building direct-from-specimen phenotypic rapid ID/AST assays using live cells on our proprietary instrument and consumable platform.

To prepare for and manage clinical studies for our diagnostic assays, we are hiring a Clinical Research Associate to join our Clinical Affairs team. In this role, you will support external studies, including site selection, site initiation visits and routine monitoring. Serving as the liaison between clinical sites and Pattern teams, you’ll have the opportunity to collaborate across the organization including with Assay Development, Hardware, Software, Quality, and Regulatory. This role is for you if you enjoy combining your passion for microbiology with organizational and communication skills to support building new partnerships with clinical study sites.

This role is currently set up to be remote, but it can be adjusted to a hybrid or onsite role for anyone located in the Austin area preferring that work style. It will require an average of 25% travel and up to 75% travel during peak times.

Goals

• 90 Days: Perform site/data monitoring for clinical studies
• 90 Days: Organize and maintain study documents and data files
• 90 Days: Contribute to qualification of potential clinical study sites for upcoming studies
• 90 Days: Help coordinate clinical specimen shipments from clinical partners to Pattern
• 6 Months: Support Pneumonia ID/AST clinical study initiation at external sites
• 6 Months: Organize Pneumonia ID/AST clinical study master files
• 6 Months: Support set up and execution of analytical validation studies (e.g., reproducibility study)

How You Will Contribute

• Set up and support sites for clinical trials and other external studies—including providing training, maintaining close communication, organizing study documents, and helping with study logistics
• Optimize clinical study workflows and implementation
• Ensure studies are conducted, monitored, and documented according to GCP and Pattern Bioscience SOPs
• Build and validate electronic data capture systems
• Review and monitor data from active external studies, ensuring all errors are caught and queries appropriately resolved
• Build strong relationships and credibility with other internal teams as well as external clinical sites and vendors
• Collaborate with Pattern’s R&D and/or Microbiology teams
• Contribute to drafting SOPs, study manuals, and other clinical documents

We'd Love to Hear from You if You

• Self-prioritize work effectively, applying strong organizational skills
• Demonstrate attention to detail and accuracy when delivering and following instructions and when reviewing and generating data and documents
• Are teachable and love new challenges and learning new technology
• Adapt quickly to changing priorities, timelines, and goals; are flexible with shifting strategies; and think nimbly to generate creative solutions
• Love developing and creating organizational infrastructure
• Have strong communication skills and a customer-centric mindset

Desired Education & Experience

• B.S. in biological sciences, medical laboratory science, or related field with hands-on lab experience in microbiology and applied knowledge of bacteriology
• Experience in actively managing multi-site diagnostic device clinical trials and managing clinical study documentation/clinical study master files
• Experience working with clinical specimens and microorganisms
• Working knowledge of general workflows in a clinical microbiology laboratory, including Gram-stains, organism identification, conventional culture, and AST
• Knowledge and experience in performing and interpreting antibiotic susceptibility testing (AST) (could be in an industry, research, or clinical laboratory setting)
• Knowledge of GCP and FDA regulations related to conducting IVD/device clinical trials

Application Instructions: Instead of a cover letter or overly customizing your resume, we invite you to answer a few questions in the application process to highlight your applicable skills and background.

Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.

Benefits

* Health insurance

* 401k Matching

* Paid Time Off

* The opportunity to make a global impact

To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.

We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, neurodiversity, status as a qualified individual with disability, protected veteran status, hair texture or protective hairstyle, or any other characteristic protected by law.