Clinical Research Associate

3 days ago

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Pattern Bioscience

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Our mission is simple: We will improve the world's most important health decisions.

11 - 50

💰 $28.7M Series C on 2023-04

Description

• Set up and support sites for clinical trials and other external studies • 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

Requirements

• 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

Benefits

• 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)