Job Description

Job Summary

We are seeking an experienced Clinical Research Associate (CRA) to support clinical trials for a diagnostic device. The ideal candidate will have experience with monitoring in the context of infectious diseases (specifically HIV) and diagnostic devices. The role requires someone who is familiar with 510(k) submissions, Class I devices, and human factors testing. This position is hybrid, requiring onsite presence for monitoring and some travel to clinical sites.

Key Responsibilities

• Perform on-site monitoring of clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements and protocol.
• Assist in the preparation, execution, and oversight of clinical trials, specifically in the diagnostic device space.
• Monitor data collection, conduct source document verification, and ensure patient safety at all times.
• Coordinate with clinical trial sites to ensure compliance with trial protocol, Good Clinical Practice (GCP), and FDA regulations.
• Support the review and evaluation of clinical data, identifying issues and ensuring timely resolution.
• Assist with preparing and reviewing regulatory documentation, including 510(k) submissions for diagnostic devices.
• Review and provide input on human factors testing for device development.
• Travel to various clinical sites as needed to ensure monitoring requirements are met.
• Collaborate closely with project managers and other stakeholders to ensure project milestones are achieved.

Qualifications

• 2+ years of experience as a Clinical Research Associate (CRA), with a focus on diagnostic devices or infectious disease (preferably HIV).
• Experience with 510(k) submissions and working with Class I devices.
• Familiarity with human factors testing in medical device development (not required but highly preferred).
• Strong understanding of clinical research regulations (GCP, FDA, etc.) and ability to monitor studies in compliance with regulatory requirements.
• Ability to work independently and with minimal supervision, while maintaining a high level of organization and attention to detail.
• Excellent communication and interpersonal skills to effectively liaise with clinical sites and other stakeholders.
• Willingness and ability to travel as needed for on-site monitoring.

Additional Information

• This is a 6-month contract role, with potential for extension depending on project needs and performance.
• Full-time hours (40 hours per week), with hybrid working arrangements (onsite monitoring required).
• Previous experience with diagnostic devices and/or HIV-related clinical trials is highly desirable.

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