Senior Clinical Research Associate

Job title:

Senior Clinical Research Associate

Company:

Philips

Job description

Job Title Senior Clinical Research AssociateJob DescriptionYour role:

• Owning the overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems/risks, creating mitigation plans, and taking actions or corrective actions using timely communication for daily monitoring and site mgmt.
• Supporting site identification, selection, i.e. recruitment and qualification, and initiation. As well, developing the monitoring plan for clinical studies.
• Acting as Clinical Study Manager for designated clinical studies under the guidance of your manager and supporting other studies in this role as applicable. Contributing to protocol development and study related documents, such as informed consent related to monitoring activities.
• Supporting electronic data capture (EDC) user acceptance testing and training as applicable, while liaising with project team members regarding study site issues. As well as assisting with resolution of investigational site/data queries.
• Initiating study status reports, essential documents, and accurate study files, while supporting the development of regulatory binders and investigational product shipments as needed.
• Traveling to study sites for meetings and monitoring visits upon request (i.e. 60% travel of which 10% international).

You’re the right fit if:

• You’ve acquired 5+ years of experience in conducting/executing clinical trials (healthcare setting, CRO, medical device and/or in medical technology and/or industry) as a Senior Clinical Research Associate.
• Your skills include a demonstrated working knowledge of GCP, ICH guidelines, FDA/EU regulations.
• You have a bachelor’s degree in biological sciences or healthcare.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

. * You’re autonomous, fluid and have the ability to follow thorugh 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 PhilipsWe 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.

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.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 .Additional InformationUS 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.#LI-PH1This 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.

Expected salary

Location

Cambridge

Job date

Wed, 15 May 2024 05:21:41 GMT

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