In this role, you have the opportunity to
Clinical research coordinator responsible for regulatory, trial master file, completion of clinical trial management system updates, oversight of social cast, oversight and receipt of requests into SharePoint and processing purchase orders and timesheets.
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, 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 no degree 5+ years’ experience as a clinical research coordinator
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
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.