Clinical Trial Assistant
- Brazil
- Clinical Trial Support
- ICON Strategic Solutions
TA Business Partner
- Icon Strategic Solutions
About the role
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The Clinical Trial Assistant performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements.
What you will be doing:
- Performs a variety of routine essential document collection, review, negotiation, to ensure successful site activation and maintenance and close out tasks under generalsupervision.
- Performs recruitment of study sites, ensuring activities, documents and all other clinical data are accurately tracked and documented for the project lifecycle . Escalates issues as needed.
- Complete submissions and notifications to regulatory authorities, ethics committee and other bodies.
- May serve as a patient management associate (conduct patient interviews, answer questions, follow up on issues).
- Performs and documents clinical data review and query creation, query
resolution, offsite central monitoring contacts/visits and site management
communications as outlined in the study plans (and/or other processes). - Sets up and maintains study documentation in applicable systems, e.g., clinical trial management system (CTMS), TMF system, applicable site/sponsor systems according to project protocol, applicable SOPs and project plans.
You are:
- Undergraduate degree or its international equivalent in clinical, science, or health related field
- Prior experience using computerized information systems.
- Clinical trials support or pharmaceutical industry experience preferred.
- Advanced English; fluent in host country language required
- Experience with PC-Windows, word processing, and electronic spreadsheets preferred.
Office based or clinical employment experience preferred. - Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
- Office based
Why 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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
01/26/2023
Summary
The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j
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Teaser label
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