Assoc CRA - CRA School

IQVIA; Buenos Aires; On-site; ARS 54,524,000 - 72,699,000; Full time

Job summary

IQVIA in Buenos Aires, Argentina, offers a structured training program to gain knowledge and skills to independently conduct clinical monitoring visits in accordance with study protocol, SOPs, GCP, and regulatory requirements.

The role emphasizes training, supervision, site monitoring visits, regulatory tracking, TMF/ISF maintenance, and collaboration with study teams to support project delivery. Travel availability is required.

Qualifications

• Bachelor's Degree in scientific discipline or health care (Required).
• Monitoring course completed (Pref).
• Based in Buenos Aires (CABA / GBA).
• Availability to travel.
• Written and verbal communication skills including good command of English.
• Prior clinical experience preferred.
• Some organizations may require 2 years of clinical experience.

Responsibilities

• Perform site monitoring visits under supervision per protocol and SOPs.
• Complete appropriate training to perform job duties.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Ensure TMF/ISF are maintained per GCP/ICH and local regulations.
• Create and maintain site management documentation and visit reports.
• Collaborate with study team for project execution support.
• Assist in startup phase and propose site recruitment ideas.

Skills

Good communication

Travel readiness

MS Word

MS Excel

PowerPoint

Time management

Problem solving

Team collaboration

GCP/ICH knowledge

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Laptops/iPhone usage

Job description

Buenos Aires, Argentina

Full time

R1562678

Job Overview

Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

Essential Functions

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Gain experience in study procedures by working with experienced clinical staff.
• Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
• Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
• Under close supervision, ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
• Under close supervision may support start-up phase.
• Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

Qualifications

• Bachelor's Degree in scientific discipline or health care (Required)
• Monitoring course completed (Pref)
• Based in Buenos Aires (CABA / GBA)
• Availability to travel
• Written and verbal communication skills including good command of English language.
• Prior clinical experience preferred.
• Some organizations may require 2 years of clinical experience.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• 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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