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

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

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 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.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, and 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.