Sr Cra 3, Brazil, Iqvia Biotech PCD

IQVIA; São Paulo; Vor Ort; BRL 150.000 - 210.000; Vollzeit

Zusammenfassung

IQVIA Biotech is seeking an experienced Senior Clinical Research Associate (Sr CRA 3) to join our Clinical Monitoring team in Brazil. You will independently manage and monitor clinical trial sites to ensure studies are conducted in compliance with study protocols, GCP, ICH guidelines, regulatory requirements, and sponsor expectations.

The role requires a Bachelor's degree and at least four years of on-site monitoring experience, with strong organizational and communication skills, and

Qualifikationen

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

Aufgaben

• Site monitoring activities including qualification, initiation, routine monitoring, and closeout visits.
• Oversee site performance, track milestones, review source documentation, and manage data queries.

Kenntnisse

GCP knowledge

ICH guidelines

Organizational skills

Communication skills

Problem-solving

Ausbildung

Bachelor's degree in science/healthcare related discipline

Tools

Microsoft Office

Clinical trial systems

Jobbeschreibung

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 Brazil. 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.

Responsibilities

• 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.

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.

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