Study Start Up Associate I
4 semanas atrás
As a Study Start Up Associate I at ICON Strategic Solutions, you will play a pivotal role in accelerating the development of our customers' drugs and devices through innovative solutions.
You will be dedicated to one of our clients, embedded in their working environment, systems, and processes. Your responsibilities will include writing ADaM specifications, programming ADaM datasets, programming efficacy outputs, and submission work.
Key Responsibilities:- Perform investigator recruitment activities utilizing phone scripts, questionnaires, study site materials, and other tools for evaluating investigative sites.
- Utilize the Clinical Trial Management System (CTMS) to track investigator recruitment activities accurately.
- Collect, review, maintain, and close-out essential documents, ensuring sponsor and investigator obligations are met and in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Support investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
- Knowledge of local regulatory authority drug research and development regulations.
- Experience with ethical submission (CEP and CONEP).
- Clinical trials support or pharmaceutical industry experience.
- Advanced English language proficiency.
We value diversity, inclusion, and belonging at ICON Strategic Solutions. Our success depends on the quality of our people, and we strive to create a culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a range of benefits focused on well-being and work-life balance opportunities for you and your family.
Visit our careers website to learn more about the benefits of working at ICON Strategic Solutions: https://careers.iconplc.com/benefits
We are committed to providing an inclusive and accessible environment for all candidates. ICON Strategic Solutions is an equal opportunities employer and welcomes applications from diverse candidates. If you require reasonable accommodations during the application process, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
We encourage you to apply, even if you're unsure if you meet all the requirements. We're looking for talented individuals who can contribute to our team's success.
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