Senior Clinical Trial Admin & TMF Coordinator

IQVIA LLC; Lisboa; Presencial; EUR 30 000 - 42 000; Tempo integral

Resumo da oferta

IQVIA LLC is seeking a motivated Clinical Trial Administrative Assistant to support the CRA and RSU teams in delivering accurate TMF documentation and project records.

You will help prepare, file, and archive documents, coordinate CRFs and data flow, and may accompany CRAs on site visits after training. Strong English and Portuguese communication and organizational abilities are required.

Qualificações

• High School Diploma or equivalent.
• Req 2 years of experience as a CTA (Clinical Trial Assistant).
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English and Portuguese languages.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Basic knowledge 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.

Responsabilidades

• Assist CRAs and RSU with updating and maintaining TMF and project documents.
• Prepare, handle, file and archive clinical documentation and reports per SOP.
• Periodically review study files for completeness.
• Coordinate tracking and distribution of Clinical Trial Supplies and maintain tracking information.
• Coordinate tracking of CRFs, queries and clinical data flow.
• Act as a central contact for project communications and documentation.
• May accompany CRAs on site visits to assist with monitoring duties after training.
• Collaborate on preparation, handling and archiving of clinical docs per SOP.

Conhecimentos

English proficiency

Portuguese proficiency

Time management

MS Word/Excel/PowerPoint

Formação académica

High School Diploma or equivalent

2 years CTA experience

Education/training/experience mix

GCP/ICH regulatory knowledge

Ferramentas

Microsoft Word

Excel

PowerPoint

Descrição da oferta de emprego

IQVIA LLC is seeking a motivated Clinical Trial Administrative Assistant to support the CRA and RSU teams in delivering accurate TMF documentation and project records.

You will help prepare, file, and archive documents, coordinate CRFs and data flow, and may accompany CRAs on site visits after training. Strong English and Portuguese communication and organizational abilities are required.