SrCRA1 - FSP | Argentina

QPL IQVIA RDS Poland Sp. z o.o.; Buenos Aires; Sur place; ARS 92 241 000 - 138 361 000; Plein temps

Résumé du poste

IQVIA Inc in Buenos Aires is seeking a Senior Clinical Research Associate (CRA) to plan, execute and manage clinical trials, ensuring data integrity and regulatory compliance across multiple sites.

Responsibilities include site selection, initiation, monitoring and close-out visits, developing recruitment plans, training site staff, monitoring quality, tracking submissions and data queries, and using CTMS/EDC systems; some travel will be required.

Qualifications

• Bachelor’s degree in health care or a scientific discipline.
• Minimum 4 years of on-site monitoring experience.
• Advanced English; strong knowledge of GCP/ICH guidelines.
• Proficiency in CTMS and EDC systems.

Responsabilités

• Performing site visits and monitoring activities.
• Supporting the development and execution of subject recruitment plans and protocol training.
• Ensuring data quality and the integrity of site practices; escalating issues as needed.
• Managing regulatory submissions, CRF completion, and data query resolution.
• Travel as required and effective cross-functional collaboration.

Connaissances

Advanced English

Communication skills

Time management

Independence

Teamwork

Formation

Bachelor’s degree in health care or scientific discipline

Outils

CTMS

EDC

Description du poste

The Senior Clinical Research Associate (CRA) will play a crucial role in the planning, execution, and management of clinical trials. This position requires a highly skilled and experienced professional who can ensure the integrity of clinical data, compliance with regulatory requirements, and the overall success of clinical research projects.

While projects vary, your typical responsibilities might include:

• Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
• Supporting the development of a subject recruitment plan
• Establishing regular lines of communication plus administering protocol and related study training to assigned sites
• Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

You will need to be comfortable collaborating and communicating with a variety of colleagues and customers.

Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.

REQUIREMENTS

• A Bachelor's degree in a health care or other scientific discipline or educational equivalent
• At least 4 years of on-site monitoring experience.
• Advanced in English.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel as required.

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.

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.