Sr CTA

IQVIA Inc; Tandil; On-site; ARS 49,505,000 - 80,446,000; Full time

Job summary

IQVIA Inc. is seeking a diligent Clinical Trial Assistant to support the CRA and RSU teams in maintaining the Trial Master File and related documentation.

The role emphasizes accuracy, timely updates, and collaboration across study sites to ensure compliance with GCP/ICH guidelines. The ideal candidate holds a life sciences degree, has English proficiency, and is experienced with MS Word, Excel, and PowerPoint.

Qualifications

• Bachelor’s degree in Life sciences or related field.
• 1 year in clinical research experience strongly preferred.
• Advanced level of English.
• Proficiency in Microsoft Word, Excel and PowerPoint.
• Effective written and verbal communication skills.
• Effective time management and organizational skills.
• Knowledge of applicable clinical research regulatory requirements (GCP/ICH).
• Knowledge of applicable protocol requirements.

Responsibilities

• Assist CRAs and RSU team with updating and maintaining TMF and documents.
• Coordinate handling, filing, and archiving of clinical documentation per SOPs.
• Assist with periodic review of study files for completeness.
• Distribute Clinical Trial Supplies and maintain tracking information.
• Coordinate tracking of CRFs, queries and data flow.
• Act as central contact for project communications and documentation.
• Mentor and onboard new CTAs; assist with training.
• May lead CTA study teams or interview potential new hires.
• May accompany CRAs on site visits for monitoring duties.
• Participate in quality or process-improvement initiatives.

Skills

Advanced English

MS Office

Communication

Time management

Relationship building

GCP/ICH knowledge

Protocol knowledge

Education

Bachelor's degree in Life sciences

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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.