Overview:
As a IHCRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be partnering with one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world's most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer's and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.
Responsibilities:
What you will be doing:
An In-House CRA (IHCRA) is a critical role as in-house CRAs work independently in the field and are the face of the company in the investigative site community. They are also critical as they represent the customer in the prescribing community. In-house CRAs are responsible for ensuring that patients' rights and safety are protected and that clinical trials are conducted per regulations and the protocol.
* Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
* Utilizes the Clinical Trial Management System (the CTMS) to ensure investigator recruitment activities are accurately tracked.
* Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP
guidelines.
* Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
* Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
* Documents site and Sponsor contact and study interactions in a timely and professional manner.
Qualifications:
You are:
* Minimum 6 months of related experience.
* Experience with PC-Windows, word processing, and electronic spreadsheets required.
* Knowledge of local regulatory authority drug research and development regulations required.
* Clinical trials support or pharmaceutical industry experience required.
* Financial experience, budget management and payment to vendors.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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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