Job TitleSr. Clinical Research Associate
Job Description
Your role:
- Acting as the Senior Clinical Research Associate for designated clinical studies, while providing leadership in the execution and management of clinical studies, to deliver high quality data to support Philips businesses. Ensuring the clinical studies are monitored and conducted according to procedures, including up to date and complete trial master files, regular review of data, and assurance that monitoring reports and follow-up documentation are completed and updates uploaded in Clinical Trial Management System (CTMS).
- Supporting output to Daily Leadership Boards via maintenance of the CTMS and ensuring monitoring plans are created and followed with proper monitoring documentation uploaded into the applicable Trial Master Files.
- Qualifying, selecting, training, and monitoring internal and external study investigators and study documentation. Ensuring that assigned site staff are appropriately trained on study protocol and other study documents.
- Supporting electronic data capture (EDC) user acceptance testing and training as applicable.
- Overseeing and supporting the creation of trial master files, regulatory binders, source documents, including shipping and associated documentation. Ensuring that Purchase Orders are created prior to the start of a study and invoices are paid on time.
- Travel expected up to 30%.
You're the right fit if:
- You've acquired 5+ years of experience in executing clinical studies in a healthcare, Clinical Research Organization or medical device setting.
- Your skills include experience in site assessment and monitoring. You have a working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations.
- You have a bachelor's or master's degree in a science or healthcare discipline.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
- You're autonomous, fluid and have the ability to follow through on timelines, projects and related tasks with limited direction. You have a proven track record for collaborating across multiple cross functional teams and are a strong and efficient communicator, both written and verbal.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge, MA.
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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