Sr. CRA 3, Argentina, IQVIA Biotech

IQVIA LLC; Buenos Aires; Presencial; ARS 1.800.000 - 2.400.000; Jornada completa

Descripción de la vacante

IQVIA Biotech in Argentina is seeking an experienced Senior Clinical Research Associate (Sr CRA 3) to independently monitor clinical trial sites, ensuring adherence to protocols, GCP, ICH guidelines, regulatory requirements and sponsor expectations.

Responsibilities include site qualification/initiation, routine monitoring and closeout visits; training site staff; mentoring junior CRAs; and collaborating with cross-functional teams to drive study success in a fast-paced environment.

Formación

• 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.
• Excellent organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office applications and clinical trial systems.

Responsabilidades

• Conduct site qualification, initiation, routine monitoring, and closeout visits.
• Partner with investigative sites to support patient recruitment and retention.
• Provide protocol and study-related training to site staff.
• Proactively identify and resolve quality or compliance issues.
• Oversee site performance, track study milestones, and review source documentation.
• Manage data query resolution and maintain regulatory/essential documents.
• Document monitoring activities through timely, accurate reports.
• Collaborate with cross-functional teams to support trial execution.
• Mentor junior CRAs through co-monitoring and training activities.

Conocimientos

GCP knowledge

ICH guidelines

FDA regulations

Site monitoring

Organizational skills

Communication skills

Problem-solving

Mentoring

Cross-functional collaboration

Educación

Bachelor’s degree in science/healthcare

Herramientas

Microsoft Office

Clinical trial systems

Descripción del empleo

Senior Clinical Research Associate (Sr CRA 3) – Argentina

IQVIA Biotech, a full-service CRO, is 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 comply with protocols, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, regulatory requirements, and sponsor expectations.

Responsibilities

• Conduct site qualification, initiation, routine monitoring, and closeout visits.
• Partner closely with investigative sites to support patient recruitment and retention efforts.
• Provide protocol and study‑related training to site staff.
• Proactively identify and resolve quality or compliance issues.
• Oversee site performance, track study milestones, and review source documentation.
• Manage data query resolution and ensure regulatory and essential documents are maintained.
• Document monitoring activities through timely and accurate reports.
• Collaborate with cross‑functional teams to support the successful execution of clinical trials.
• 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.

All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions will be treated in accordance with applicable law.