Clinical Research Specialist (CRS)

Masimo • Irvine, CA

81d • $90,000 - $125,000

About The Position

The Clinical Research Associate is responsible for clinical studies, site management and compliance monitoring of assigned clinical projects undertaken in support of a given product line or marketing initiative. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Department Operating Procedures (DOP).

Requirements

• Experienced with Good Clinical Practice (GCP) in conduct of clinical studies.
• 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, graphing and plotting results 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.
• Ability to travel to data collection sites, local and domestic, may require up to 25-50% of time.
• Ability to lift and carry up to 20 pounds.

Nice To Haves

• 3-6 years Clinical Research experience.
• Experience with medical devices.
• Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, physiology).
• Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements.
• Preferably certified as a Clinical Research Associate.

Responsibilities

• Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision.
• Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials.
• Contribute to clinical study design, proposals, protocols, etc.
• Effectively work and communicate with investigator, staff and patients.
• Conduct site monitoring (qualification, initiation, periodic monitoring and close out visits).
• Monitor safety reviews and adverse event reporting for investigational medical devices.
• Ensure identification and reporting of safety issues.
• Ensure accountability of Investigational Devices and study supplies.
• Perform monitoring activities per Clinical Investigational Plan.
• Ensure complete reporting and proper documentation of monitoring activities.
• Ensure sites are identifying issues and implementing corrective and preventative actions.
• Suggest improvements to departmental procedures relating to GCP monitoring aspects.
• Understand and operate Masimo products, data acquisition systems.
• Ensure essential study documents are accurate, complete, and properly organized.
• Conduct basic data analysis using spreadsheets.
• Writes clear, succinct and detailed clinical study and technical summary reports.
• Ability to travel extensively, perhaps 25-50% of the time.
• Conduct full range of data collection duties.
• Be able to lift and carry up to 20 pounds.
• Perform special projects as requested.

Benefits

• 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 and Cafe

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees