Study Support Assistant - Campinas

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As a Study Support Assistant you will be joining the brightest minds in the industry to transform clinical research.

You will be partnering with a global pharmaceutical company passionate about transforming patients’ lives and committed to scientific rigor, unassailable ethics, and access to medical innovations for all.

What you will be doing:

The Study Support Assistant will support administrative activities at sponsor's sites. 

Pre-screening and screening phase:

• Support the submission of the protocol and other documents to the ethics committee (EC) for approval and the development and maintenance of files and binders.

During trial conduct:

• Assist with scheduling patient visits.
• Transcription of source document datapoints into EDC including query response according to the timelines and which can be clearly accessed in source documents.
• Submission of applicable trial documents to the ethical and regulatory entities.
• Archive and maintenance of the regulatory folders and binders.
• On-site and off-site monitoring visit support, such as communication with CRAs for scheduling visits, providing access to site documentation and supplies to CRA reviews, accommodate meetings with site staff, etc.
• Audit support, as needed.
• Manage meetings, as needed.

At closure and follow-up:

• Support scheduling of follow-up visits.
• Completion of queries and CRFs in order to achieve DBL in the expected timeline.
• Support the resolution of any open action item at the site.
• Support with study close-out visits.

What you need: 

Bachelor's degree in a Science related field.

• Experience working with administrative activities in clinical trials.
• Read, write and speak fluent English; fluent in host country language required.

Why ICON:

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with varied skills, perspectives & backgrounds working together across 40 countries. 

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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