Sr CTA

IQVIA Inc; Buenos Aires; On-site; ARS 64,975,000 - 83,540,000; Full time

Job summary

IQVIA in Buenos Aires, Argentina, seeks a Full-Time Clinical Trial Assistant to support daily administrative activities alongside CRAs and Regulatory and Start-Up teams. You will help update and maintain the Trial Master File, coordinate documentation, and assist with data flow and study file completeness.

The role includes collaboration with the clinical team on documentation handling and archiving, and mentoring junior CTAs. A Life sciences degree and English proficiency are required.

Qualifications

• Bachelor’s degree in Life sciences or related field.
• 1 year in clinical research experience strongly preferred.
• Advanced level of English.
• Computer skills including proficiency in MS Word, Excel and PowerPoint.
• Effective written and verbal communication skills.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships.
• Knowledge of GCP/ICH guidelines as provided in training.
• Knowledge of protocol requirements as provided in training.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF documents and systems.
• Collaborate on preparation, handling, distribution, filing, and archiving of clinical documentation.
• Assist with periodic review of study files and completeness.
• Coordinate tracking and management of CRFs, queries and data flow.
• Serve as central contact for the clinical team for communications and documentation.
• Mentor less experienced CTAs and assist with onboarding.

Skills

English proficiency

MS Word

MS Excel

PowerPoint

Communication

Time management

Teamwork

Regulatory knowledge

Education

Bachelor’s degree in Life sciences

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Buenos Aires, Argentina

Full time

R1578292

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.
• Collaborate with 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.
• Assist with periodic review of study files and completeness.
• Collaborate with CRAs and RSU on the 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.
• Act as a mentor for less experienced Clinical Trial Assistants (CTAs).
• Assist with training and onboarding of new CTAs.
• May serve as subject matter expert for business processes.
• May lead CTA study teams.
• May assist with interviewing and screening of potential new team members
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
• May participate in departmental quality or process improvement initiatives.

Qualifications

• Bachelor’s degree in Life sciences or a related field.
• 1 year in clinical research experience strongly preferred.
• Advanced level of English.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Effective written and verbal communication skills.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• 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, 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.

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.

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