CV BANK- Senior CRA - In-Vitro Diagnostics
- Boston, Tuscon, United States
- Clinical Monitoring
- ICON Strategic Solutions
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
ICON is looking for a Senior CRA with IVD (in vitro diagnostics) experience!
Responsibilities:
The Clinical Research Associate (CRA) will lead in designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include:
• Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements;
• Validating product performance claims;
• Supplying data for critical Regulatory submissions;
• Defining the functional and clinical utility of investigational products, and
• Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders.
• Performing or coordinating aspects of external clinical studies including site selection, study initiation, site monitoring, and study closeout.
• Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met.
• Interfacing with staff to support post launch activities.
• Reviewing cases with investigators to resolve discrepancies.
• Understanding and implementing federal regulations, helping to develop standard operating procedures in order to ensure that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, policies and procedures.
Qualifications:
5 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience preferred
• CRA certification by recognized professional organization is a plus, but not mandatory
• Excellent oral and written communication skills
• Excellent planning, organizing, interpersonal and leadership skills
• Ability to work independently to make sound decisions and to analyze and solve problems
• Demonstrated experience in computer skills to include Microsoft Word, Excel, and basic templates
• Statistical knowledge
• Supervision experience or experience in a leadership role preferred
Minimum - Bachelor's degree in relevant field. Medical technology degree preferred, but not required if R&D background is adequate
Application process
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Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
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Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
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