Clinical Research Lab RN

Masimo Corporation; Irvine (CA); Hybrid; USD 100,000 - 120,000; Full time

Benefits offered by this job

Remote work arrangement

Benefits package

Job summary

Masimo, a Danaher operating company, is seeking a Clinical Research Lab RN in Irvine, CA to support and lead clinical studies for R&D, regulatory filings, and marketing initiatives.

The position reports to the Sr Director, Clinical Lab Operations and is based on-site with eligibility for remote work. You will contribute to protocol development, IRB submissions, data collection, and patient safety oversight.

Qualifications

• Licensed RN in California is required.
• Current ACLS certification is required.
• Excellent written and verbal communication skills are essential.
• Demonstrates advanced judgment in executing/overseeing clinical studies.

Responsibilities

• Venous puncture, finger sticks, venous line removal, and arterial dressing (minimum requirement phlebotomist/medical assistant).
• Place IV catheters and perform blood draws from established lines; numb venous sites; provide medical history and post-care instructions; assist in emergency medical administration.
• Assist in placing arterial lines and qualifying subjects based on medical history; monitor vitals during invasive studies; supervise CPR when needed.
• Assist with a broad range of clinical trial duties including equipment setup, materials inventory, data collection, verification and transfer.
• Contribute to study proposals, protocols, CRFs and other documents applying principles of clinical study design.
• Prepare and review informed consents, IRB submissions, CRFs and related materials to ensure quality, consistency and compliance.
• Monitor safety reviews, protocol deviations, device deficiencies and adverse event reporting per GCP, FDA and MDD regulations.

Skills

Communication skills

Education

Licensed RN in California

ACLS certification

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Masimo, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you'll be part of a culture that's driven by passion, challenging the status quo, and making an impact in the lives of others.

Learn about the Danaher Business System which makes everything possible.

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:

• Venous puncture, finger sticks, venous line removal, and arterial dressing (minimum requirement phlebotomist/ medical assistant).

• Placing Intravenous catheters, completing blood draws from established lines, numbing venous sites, medical histories, post care medical instructions, and assisting in emergency medical administration (minimum requirement registered nurse/ a licensed vocational nurse may perform some of these duties).

• 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.

The essential requirements of the job include:

• 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

It would be a plus if you also possess previous experience in:

• 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

Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At Masimo we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Masimo can provide.

The annual salary rangeORthe hourly range for this role is $100,000 - $120,000.This is the range that we in good faith believe is the range ofpossible compensationfor this role at the time of this posting. This range may bemodifiedin the future.

This job is also eligible for up to a 10% annual bonus.

We offercomprehensivepackage of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].