Sr Clinical Trial Assistant - Study Start-Up & Regulatory - Sponsor Dedicated -

IQVIA; Oeiras; Presencial; EUR 18 000 - 28 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Detail-oriented Clinical Trial Assistant to support daily administrative activities with CRAs, RSU, and TMF delivery.

You will assist with document handling, site visits, and data flow for regulatory compliance, under SOPs, in a collaborative, fast-paced environment. The role requires English and Portuguese communication and prior CTA experience.

Qualificações

• High School Diploma or equivalent required.
• 2 years of CTA experience.
• Computer skills including Word, Excel and PowerPoint; English and Portuguese.

Responsabilidades

• Assist CRAs and RSU with updating and maintaining TMF and study documents.
• Prepare, handle, distribute, file and archive clinical documentation and reports according to SOPs.
• Assist with periodic review of study files for completeness.
• Coordinate tracking of Case Report Forms, queries and data flow.
• Act as central contact for project communications and documentation.
• May accompany CRAs on site visits for monitoring duties after training.

Conhecimentos

English (written/spoken)

Portuguese (written/spoken)

Time management

Communication

Formação académica

High School Diploma or equivalent

Ferramentas

Microsoft Word

Microsoft Excel

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.

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 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 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.

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.com.

IQVIA 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.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.