Clinical Trials Assistant I

IQVIA LLC; São Paulo; Híbrido; BRL 40 000 - 66 000; Tempo integral

Resumo da oferta

IQVIA in São Paulo, Brazil seeks a Clinical Trials Assistant I to support daily administrative activities, coordinating with CRAs and RSU to keep TMF up to date and audit-ready. In this hybrid role, you will assist with document preparation, filing, archiving, and tracking of CRFs and study documents in accordance with GCP, ICH guidelines and SOPs.

Strong English communication and Microsoft Office skills are required; CEP/CONEP experience is a plus, and you may accompany CRAs on site visits

Qualificações

• High School Diploma or equivalent required.
• CEP/CONEP experience preferred.
• Proficient with MS Word, Excel and PowerPoint.
• Must have good written and verbal English communication.
• Knowledge of GCP/ICH guidelines and protocol basics.

Responsabilidades

• Assist CRAs and RSU with TMF updates and document control.
• Prepare, file, archive and distribute clinical documents and reports.
• Review study files for completeness during cycles.
• Support tracking of CRFs, queries and data flow.
• Serve as central point of contact for project communications.
• May accompany CRAs on site visits after training.

Conhecimentos

Communication skills

MS Word

MS Excel

PowerPoint

English proficiency

Formação académica

High School Diploma or equivalent

Ferramentas

Microsoft Office Suite

Descrição da oferta de emprego

**Clinical Trials Assistant I****Hybrid Role - Location: São Paulo, Brazil****Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.**Essential Functions** • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. • Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. • Assist with periodic review of study files for completeness. • Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.**Qualifications** • High School Diploma or equivalent.• Previous experience working with CEP/CONEP. • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint. • Written and verbal communication skills including good command of English language. • Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training. • Knowledge of applicable protocol requirements as provided in company training.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.