Senior Clinical Research Associate
Job TitleSenior Clinical Research AssociateJob DescriptionSr.
Clinical Research AssociateAn opportunity to be a part of business-critical projects within the Hospital Patient Monitoring Clinical Operations team- responsible for monitoring of clinical research studies involving human subjects from its inception to close-out according to budget, timelines, and delivery of high-quality data in compliance to all applicable regulations and Philips procedures.
Your role:
Part of the Clinical Operations Team.
This team member supports the Clinical Study Manger (CSM) with study execution and deliverables across Philips's Hospital Patient Monitoring (HPM) under the Monitoring Business.
Monitoring clinical sites Generation of Study Documents (Clinical Monitoring Plans/ Informed Consents/ data source work sheets/Device accountability/training slides and work instructions) Site start up to Site Activation (SA) to include Investigator Site File/Inventory and Device Shipping/ labeling/Site Management and Team meeting facilitator.
Study Duration (Enrollment tracking/Key Performance Indicators/Adverse Events/ Serious Adverse Events) Database Lock (listing review as needed/ Data query & resolution/Source data verification - onsite or remotely) You're the right fit if:
You've acquired 3
years of experience in monitoring and management of clinical trials and / or clinical research experience in the medical device industry.
Your skills include knowledge in Electronic Data Capture systems (EDC), GCP /ISO14155 working knowledge, eTMF experience, experience working with cross-functional teams, working knowledge of IRB expectations/ correspondence, and familiarity with Clinical trial management systems (CTMS)and timeline driven tools.
You have a bachelor's degree in a relevant field of study You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
You work well in a team environment and perform well in a cross-functional team.
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.
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 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.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Recommended Skills Clinical Research Clinical Trials Clinical Works Databases Electronic Data Capture Financial Management Estimated Salary: $20 to $28 per hour based on qualifications.
Clinical Research AssociateAn opportunity to be a part of business-critical projects within the Hospital Patient Monitoring Clinical Operations team- responsible for monitoring of clinical research studies involving human subjects from its inception to close-out according to budget, timelines, and delivery of high-quality data in compliance to all applicable regulations and Philips procedures.
Your role:
Part of the Clinical Operations Team.
This team member supports the Clinical Study Manger (CSM) with study execution and deliverables across Philips's Hospital Patient Monitoring (HPM) under the Monitoring Business.
Monitoring clinical sites Generation of Study Documents (Clinical Monitoring Plans/ Informed Consents/ data source work sheets/Device accountability/training slides and work instructions) Site start up to Site Activation (SA) to include Investigator Site File/Inventory and Device Shipping/ labeling/Site Management and Team meeting facilitator.
Study Duration (Enrollment tracking/Key Performance Indicators/Adverse Events/ Serious Adverse Events) Database Lock (listing review as needed/ Data query & resolution/Source data verification - onsite or remotely) You're the right fit if:
You've acquired 3
years of experience in monitoring and management of clinical trials and / or clinical research experience in the medical device industry.
Your skills include knowledge in Electronic Data Capture systems (EDC), GCP /ISO14155 working knowledge, eTMF experience, experience working with cross-functional teams, working knowledge of IRB expectations/ correspondence, and familiarity with Clinical trial management systems (CTMS)and timeline driven tools.
You have a bachelor's degree in a relevant field of study You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
You work well in a team environment and perform well in a cross-functional team.
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.
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 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.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Recommended Skills Clinical Research Clinical Trials Clinical Works Databases Electronic Data Capture Financial Management Estimated Salary: $20 to $28 per hour based on qualifications.
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