Clinical Research Associate 3 (Andover, MA)

Purpose:
Philips Medical Systems

A leader in Healthcare, Philips Medical Systems is one of the world’s top three medical device companies. Our mission is to improve the quality of people’s lives.

Our focus areas include imaging systems, customer services, information and monitoring systems. We enjoy a number one position in several of these including X-ray, cardiovascular ultrasound, patient monitoring and automatic external defibrillators. Our HeartStart Home Defibrillator brings life-saving technology to consumers in their own homes, where the majority of sudden cardiac arrests occur. It’s just one of the many ways we deliver ‘advanced’ technology that is ‘designed around you’ and ‘easy to experience’.

Research and Development

Clinical Research Associate 3 (Andover, MA)


Job Description

Your role will be to provide clinical / engineering expertise to bring high quality and efficiency to clinical testing and product development for Philips Medical System. This will be accomplished by:

1. Active participant and contributor to requirements, specifications, use model definitions, business teams, and risk management process.

2. Coordinate planning, implementation and monitoring of Clinical Validation activities based on high-level guidance from research manager. This includes; clinical testing planning, protocol development, investigator selection, study contracting, go-live logistics, and training of internal and external personnel.

3. Provide post go-live study monitoring to insure patient safety, adherence to the protocol, adequate reporting of feedback, and adverse events in clinical test. Conduct project and process retrospectives to ensure process improvement opportunities are capitalized.

4. Writing/editing of study reports for business and regulatory submission as well as assist in the preparation of manuscripts, abstracts, book chapters, posters and in-house publications in cooperation with clinical investigators.

Philips is an Equal Opportunity Employer

Philips Employee Referral Bonus $1,500.00

Job ID 37424
REQUIREMENTS
Required Qualifications:
Experience Requirements:
Preferred Profile

Relevant BS/BA in a related health science or equivalent required, MS is preferred.
>5 years research, clinical relevant experience, or related industry experience
Demonstrated competence in management of multiple projects
Excellent written and verbal communication skills
Strong organizational and interpersonal skills
Working regulatory knowledge (FDA/21CFR812; EN540/GCP; ISO14971)
Willingness to travel (less than 35%)