In-House CRA (CTA) - São Paulo
Location
Home office | Brazil
Job description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The In-House CRA (IHCRA) 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 ICON's protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements.
- 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.
- Bachelor's degree or its international equivalent in clinical, science, or health related field
- Previous experience in clininical research with ethics submissions.
- Clinical trials support or pharmaceutical industry experience preferred.
- Read, write, and speak advanced English; fluent in host country language required
- Prior experience using computerized information systems.
- Experience with PC-Windows, word processing, and electronic spreadsheets preferred
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
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.
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