[Hiring] Clinical Research Lab RN @Danaher Corporation

Role Description

The Clinical Research Lab RN is responsible for assigned clinical trial projects undertaken in support of a given product line or marketing initiative within Masimo Corporation. This includes the execution and documentation of assigned clinical studies conducted to support R&D efforts, regulatory filings (510k or PMA), or marketing initiatives for Masimo products. This position reports to the Ahmed Alghazi Sr Director Clinical Lab Operations and is part of Clinical Research located in Irvine, CA and will be an on-site role.

In this role, you will have the opportunity to:

• Perform venous puncture, finger sticks, venous line removal, and arterial dressing (minimum requirement phlebotomist/medical assistant).
• Place intravenous catheters, complete blood draws from established lines, numb venous sites, provide medical histories, post-care medical instructions, and assist in emergency medical administration (minimum requirement registered nurse/a licensed vocational nurse may perform some of these duties).
• Assist in placing arterial lines, qualify subjects based on medical history, numb arterial sites, make informed medical decisions on drug administration during adverse events, present in lab for monitoring of vitals during more invasive clinical studies as related to subject participation and continuation, and present in a supervisory role in the case of performing CPR.
• Assist with/conduct a broad range of clinical trial duties, including equipment setup, materials inventory and operations, execution of studies according to test protocols/procedures and clinical work instructions, collect data, verify results, transcribe and transfer data.
• Assist with/conduct more complicated studies, contribute to study proposals, protocols, developing case report forms and other study-related documents while applying principles of clinical study design and research methodology to assigned research projects.
• Contribute, prepare and review study plans, informed consents, IRB submissions, case report forms (CRFs), and other study-related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects.
• Assist with monitoring safety reviews, protocol deviations, device deficiencies and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations.

Qualifications

• Licensed RN in the state of California.
• Current ACLS certification.
• Excellent written and verbal communication skills essential.
• Demonstrates advanced judgment and decision-making ability in the execution/oversight of clinical studies.

Requirements

• Familiarity with medical, pharmaceutical or medical device research.
• Basic understanding of FDA Good Clinical Practice (GCP) guidelines for Medical Devices in the conduct of clinical studies.
• Experience in Post Market surveillance of Medical Devices and Regulatory Affairs submissions for new or modified devices desirable.
• Clinical or scientific background desirable.

Benefits

• Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
• Annual salary range of $100,000 - $120,000.
• Eligible for up to a 10% annual bonus.
• Flexible, remote working arrangements for eligible roles.