NuvOx Therapeutics · 5 days ago
Clinical Research Associate
NuvOx Therapeutics is a biotechnology company based in Tucson, Arizona, focused on developing innovative oxygen therapeutics to treat life-threatening conditions involving hypoxia. The In-House CRA will support the planning, monitoring, and execution of clinical trials to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
BiopharmaHealth CarePharmaceuticalTherapeutics
Responsibilities
Conduct remote and on-site monitoring activities in accordance with the monitoring plan, ensuring high-quality data and protocol compliance
Review eCRFs and source data, resolve discrepancies, and follow up with sites to ensure timely data cleaning and query resolution
Identify, document, and escalate data quality issues, protocol deviations, and site risks to Clinical Operations leadership
Perform Investigator Site File (ISF) reviews, tracking and addressing outstanding issues
Oversee essential document management during all study phases and ensure audit-readiness Trial Master File (TMF)
Prepare, review, and file monitoring visit reports, follow-up letters, and study documentation
Ensure compliance with study protocols, GCP, SOPs, and applicable regulatory requirements
Support site initiation, training, ongoing site communication and study closeout
Support vendor oversight activities, including coordination with central labs, and other study vendors as applicable
Attend meetings and teleconferences and generate and distribute agendas and minutes
Other study related tasks as required
Qualification
Required
2–5+ years of CRA experience with direct involvement in clinical trials from start-up through closeout within pharmaceutical, biotechnology, or CRO environments
Hands-on experience performing SDV and site monitoring activities
Strong working knowledge of ICH-GCP, FDA regulations, and clinical trial operations
Highly effective team player with exceptional interpersonal skills building relationships with clinical trial sites
Ability to work independently with little oversight and attention to detail and results oriented
Experience using EDC, CTMS, and eTMF systems
Excellent organizational skills with the ability to manage multiple studies and priorities
This position requires some travel
Preferred
Minimum of a bachelor's degree in a scientific or health care discipline preferred
Company
NuvOx Therapeutics
NuvOx Therapeutics strives to advancing life-saving oxygen therapies.
Funding
Current Stage
Early StageTotal Funding
$19.04MKey Investors
National Cancer InstituteNational Institute of Neurological Disorders and StrokeNational Institutes of Health
2025-11-19Grant
2023-04-26Convertible Note
2023-04-17Grant· $0.9M
Recent News
2025-04-02
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