Clinical Trial Assistant 2 - Sponsor Dedicated - Based in Lisbon

IQVIA; Oeiras; Presencial; EUR 20 000 - 30 000; Tempo integral

Resumo da oferta

A clinical research organization is looking for a Clinical Trial Assistant in Oeiras, Portugal. This role involves assisting the clinical team with the administration and management of clinical documents, ensuring compliance and performance within project timelines. Candidates should have a High School Diploma, 1–2 years of relevant experience, and strong communication skills in English and Portuguese.

Qualificações

• 1–2 years of experience as a CTA (Clinical Trial Assistant).
• Ability to establish and maintain effective working relationships.
• Basic knowledge of Good Clinical Practice (GCP) and ICH guidelines.

Responsabilidades

• Assist CRAs and RSU with maintaining clinical documents and systems.
• Prepare, handle, and archive clinical documentation and reports.
• Act as a central contact for project communications.

Conhecimentos

Communication skills

Time management

Organizational skills

Knowledge of Microsoft Word

Knowledge of Microsoft Excel

Knowledge of Portuguese

Knowledge of English

Formação académica

High School Diploma or equivalent

Ferramentas

Microsoft PowerPoint

Descrição da oferta de emprego

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. Coordinate 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.

• May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Qualifications

• High School Diploma or equivalent

• 1–2 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 requirement, 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.