Pattern Bioscience is developing technology to rapidly identify bacterial infections and predict effective antibiotics to combat antibiotic resistance. They are seeking a Clinical Research Associate to support the management of clinical studies for their diagnostic assays.
Requirements
- Experience in actively managing multi-site diagnostic device clinical trials
- Managing clinical study documentation/clinical study master files
- Knowledge of GCP and FDA regulations related to conducting IVD/device clinical trials
- Hands-on lab experience in microbiology and applied knowledge of bacteriology
- 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)
Responsibilities
- Perform site/data monitoring for clinical studies
- Organize and maintain study documents and data files
- Contribute to qualification of potential clinical study sites for upcoming studies
- Help coordinate clinical specimen shipments from clinical partners to Pattern
- Support Pneumonia ID/AST clinical study initiation at external sites
- Organize Pneumonia ID/AST clinical study master files
- Review/monitor data from active external studies, ensuring all errors are caught and queries appropriately resolved
Other
- Become familiar with Pattern technology and assay/instrument workflows
- Participate in Clinical Study preparedness activities
- Participate in study site start up activities
- Support Pneumonia ID/AST clinical study execution at external sites
- Support set up and execution of analytical validation studies (e.g., reproducibility study)
- Build strong relationships/credibility with other internal teams as well as external clinical sites/vendors
- 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
- Assist in the build and validation of electronic data capture systems
- Collaborate with Pattern’s R&D and/or Microbiology teams
- Contribute to drafting SOPs, study manuals, and other clinical documents
- 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
- Have a customer-centric mindset
- B.S. in biological sciences, medical laboratory science, or related field
- US-based Remote, Hybrid, or in-person in Austin; average of 25% travel required with up to 75% travel during peak times
- Exempt, Full-time
- Health insurance
- 401k Matching
- Paid Time Off
- The opportunity to make a global impact
