Job Description

Job Summary:

The individual in this position 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.

Duties & Responsibilities:

• 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.
• May investigate and reply to data queries, in collaboration with relevant clinical team members.
• Assist with, maintain and/or manage device accountability.
• Assist with, maintain and/or manage maintenance of equipment records and calibration records for equipment (including laboratory analyzers).
• May be required to travel based on business needs.
• Duties limited to license in the state of California.
• May be assigned study role as sub investigator and their associated responsibilities.
• Leadership and supervision maybe required for various levels.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Licensed RN in the state of California
• Current ACLS certification
• Excellent written and verbal communication skills essential
• Must be capable of interacting with all levels of management, coworkers, investigators and subjects
• Proficiency with Microsoft Office, computer data acquisition, data analysis, and report writing
• Ability to independently set and manage multiple priorities
• Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies

Preferred Qualifications:

• Clinical or scientific background desirable
• Applies the principles of sound clinical study design and research methodology to assigned research projects
• 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

Education:

• Combination of educational and work experience demonstrating competencies to perform the duties and responsibilities of the position
• Bachelor of Science degree preferred

Compensation:

The anticipated hourly range for this position is $40 - $52 Per Hour plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience and internal equity.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center, Café. All benefits are subject to eligibility requirements.

Physical requirements/Work Environment

This position primarily works in clinical lab environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. Exposed to a hospital like setting involving hospital equipment, subjects as patients, and bodily fluids e.g. blood.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.