Clinical Research Coordinator

Job TitleClinical Research Coordinator

Job Description

In this role, you have the opportunity to

Support critical clinical research activities across multiple businesses and device platforms enabling innovation across sectors.

You are responsible for

  • Entry of data into Clinical Trial Management Software (CTMS)
  • Generation of reports in CTMS
  • Assist Clinical Research Associates with the following clinical study related activities including but not limited to:
  • Support Institutional Review Board submissions / document prep and correspondence (initial, amendments, renewals)
  • Support site / study training
  • Assist in preparation of site training / study initiation materials
  • Create and maintain study binders
  • Contact and coordinate study participant recruitment and enrollment for internal trials, including:
  • Retain documentation necessary for this process
  • Initiate, coordinate, and manage activities associated with external patient trials and focus group meetings, including locating participants, securing meeting locations, developing trial procedures, and designing survey materials
  • Conduct quality audits through monitoring internally and externally (remotely or onsite) to ensure compliance with US or international regulations
  • Maintain traceability and accountability of study devices
  • Follow procedures to order study equipment
  • Assist with device labeling, modified product process, set-up and shipments
  • Manage return and disposition of study equipment
  • Manage (generate and track) Purchase Orders (PO's) to facilitate study payments to sites and vendors
  • Data Entry and Validation
  • User Assessment Testing (UAT) of Electronic Data Capture (EDC) system develop Excel spreadsheets for data capture validate / audit per validation plan
  • Initiate and track requests for legal agreements
  • Support the timely and accurate compilation of: all study data, study reports, including SAP file / document entries
  • Maintain professional relationships with internal associates

You are a part of

This position supports global clinical and scientific affairs for Philips which is integral to the assurance of Good Clinical Practice compliance and support of business needs and new product development. Our organization works closely with regulatory, quality, marketing and research and development, among other departments.

To succeed in this role, you should have the following skills and experience

  • BA or BS in biological sciences or related field, or RN or if an Intern a student in one of these areas
  • work experience in life science or medically related field
  • prior experience providing administrative support in a clinical trial or data management setting
  • awareness and working knowledge of applicable clinical research regulatory requirements i.e., good clinical practice (GCP) and International Conference on Harmonisation (ICH) guidelines preferred
  • knowledge and experience in budgeting, accounting and contracting is preferred
  • self-motivated individual able to manage multiple tasks and priorities in an efficient manner
  • Can work independently without direct supervision as well as in a team environment
  • ability to work according to standard operating procedures
  • computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • strong written and verbal communication skills in English
  • effective time management, planning and organizational skills
  • attention to detail and accuracy in work
  • strong problem-solving skills and proactive attitude

In return, we offer you

Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

Why should you join Philips?

Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Contact

If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In case of technical difficulties, please send an email to [email protected]

(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)


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