Clinical Research Associate I

Masimo • Irvine, CA

106d • $69,000 - $90,000

About The Position

The Clinical Research Associate I (CRA I) apply professional concepts, following company policies and procedures to resolve routine projects. 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

• 1-3 years experience in clinical studies or related field, including monitoring studies at different phases.
• Experienced with Good Clinical Practice (GCP), FDA, MDD regulations.
• Excellent written and verbal communication skills essential.
• Experience in developing study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs).
• 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.
• Demonstrate 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

• Experience with medical devices.
• Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, physiology).
• Basic 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

• Works on projects and problems of limited scope, handles studies independently or with support from CRA’s and managers.
• Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision.
• Prepare and document 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 in professional, sensitive and mature manner.
• 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.
• Write clear, succinct and detailed clinical study and technical summary reports.
• Conduct full range of data collection duties.
• Pack, ship, move, unpack, set up and execute equipment for study at clinical site.
• Perform special projects as requested.

Benefits

• The anticipated salary range for this position is $69,000 - $90,000 plus benefits.
• This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

What This Job Offers

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