Clinical Research Lab RN

Danaher•Irvine, CA

2d•Onsite

About The Position

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. You will also place Intravenous catheters, complete blood draws from established lines, numb venous sites, take medical histories, provide post care medical instructions, and assist in emergency medical administration. You will assist in placing arterial lines, qualifying subjects based on medical history, numbing arterial sites, making informed medical decisions on drug administration during adverse events, be present in the lab for monitoring of vitals during more invasive clinical studies as related to subject participation and continuation, and be present in a supervisory role in the case of performing CPR. You will 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. An advanced individual may assist with/conduct more complicated studies, as well as 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. May 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. May 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.

Requirements

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

Nice To Haves

Familiarity with medical, pharmaceutical or medical device research
Basic understanding of FDA Good Clinical Practice (GCP) guidelines for Medical Devices in 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

Responsibilities

Venous puncture, finger sticks, venous line removal, and arterial dressing
Placing Intravenous catheters, completing blood draws from established lines, numbing venous sites, medical histories, post care medical instructions, and assisting in emergency medical administration
Assist in placing arterial lines, qualifying subjects based on medical history, numbing arterial sites, making 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, present in a supervisory role in the case of performing CPR.
Assist with/conduct 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.
An advanced individual may assist with/conduct more complicated studies, as well as 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.
May 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.
May 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.