Sr. CRA 3, Argentina, IQVIA Biotech

IQVIA; Buenos Aires; Presencial; ARS 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

IQVIA Biotech in Argentina seeks an experienced Senior Clinical Research Associate (Sr CRA 3) to join the Clinical Monitoring team.

You will monitor trial sites to ensure studies follow protocols, GCP, ICH guidelines, FDA regulations, and sponsor expectations, including site qualification and routine monitoring.

As a study-team member, you will track milestones, review source data, train sites, and mentor junior CRAs through co-monitoring and coaching.

Formación

• Bachelor’s degree in a scientific field.
• Minimum of 4 years on-site clinical monitoring experience.
• Strong knowledge of GCP, ICH, FDA regulations.
• Experience monitoring visits across clinical research phases.
• Excellent organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with MS Office and clinical trial systems.

Responsabilidades

• Monitor clinical trial sites to ensure adherence to protocols and GCP/ICH/FDA requirements.
• Perform site qualification, initiation, routine monitoring, and closeout visits.
• Collaborate with investigative sites to support patient recruitment and retention, and provide study training.
• Identify and resolve quality or regulatory issues and track study milestones.
• Oversee site performance, review source data, manage data queries, and maintain regulatory documents.
• Document monitoring activities with timely, accurate reports and mentor junior CRAs through co-monitoring and training.

Conocimientos

GCP knowledge

ICH guidelines knowledge

FDA regulations understanding

Monitoring visits

Organizational skills

Communication skills

Problem-solving

Multitasking

Educación

Bachelor’s degree in a scientific, healthcare, or related discipline

Herramientas

Microsoft Office

Clinical trial systems

Descripción del empleo

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

We are seeking an experienced Senior Clinical Research Associate (Sr CRA 3) to join our Clinical Monitoring team in Argentina.

In this role, you will independently manage and monitor clinical trial sites to ensure studies are conducted in compliance with study protocols, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, regulatory requirements, and sponsor expectations.

As a key member of the study team, you will perform site monitoring activities including site qualification, initiation, routine monitoring, and closeout visits. You will partner closely with investigative sites to support patient recruitment and retention efforts, provide protocol and study-related training, and proactively identify and resolve quality or compliance issues.

The Sr CRA 3 is responsible for overseeing site performance, tracking study milestones, reviewing source documentation, managing data query resolution, ensuring regulatory and essential documents are maintained, and documenting monitoring activities through timely and accurate reports. You will collaborate with cross-functional teams to support the successful execution of clinical trials and may mentor junior CRAs through co-monitoring and training activities.

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline (or equivalent combination of education and experience).
• Minimum of 4 years of on-site clinical monitoring experience.
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes.
• Experience conducting monitoring visits across multiple phases of clinical research.
• Excellent organizational, communication, and problem-solving skills.
• Ability to effectively manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office applications and clinical trial systems.

Preferred Skills

• Strong therapeutic area knowledge and protocol management experience.
• Proven ability to build productive relationships with investigative sites, sponsors, and internal study teams.
• Experience mentoring or supporting the development of junior clinical research professionals.

Join us in helping accelerate the development of innovative therapies that improve patient lives worldwide.

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.