Clinical Research Associate II - Drive Site Partnerships

AbbVie; Buenos Aires; Presencial; ARS 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

AbbVie in Argentina is seeking an experienced clinical research professional to advance AbbVie's pipeline by focusing on site engagement, protocol adherence and data integrity across investigator sites in Buenos Aires.

You will monitor trial conduct, ensure patient safety, provide training to site staff and collaborate with cross-functional teams to drive study execution in a compliant, efficient manner. Strong knowledge of GCP/ICH and local regulatory requirements is essential.

Formación

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials.
• Familiar with risk-based monitoring approach, onsite and offsite monitoring.
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.

Responsabilidades

• Serve as primary contact for investigative sites.
• Aligns, trains and motivates the site staff and principal investigator on trial goals and patient treatment principles.
• Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans.
• Advanced understanding of site engagement and ability to customize strategies for assigned study.
• Evaluate and ensure effective recruitment and retention techniques based on patient journey.
• Mentor and train less experienced CRAs and participate in global/local initiatives.
• Proactively monitor sites for risk signals and work with Central Monitoring to mitigate issues.
• Ensure data quality and timely reporting of safety events by site personnel.

Conocimientos

Clinical research monitoring

Risk-based monitoring

Cross-functional collaboration

Site training

Regulatory knowledge

Educación

Health-related disciplines qualification

Herramientas

CRM tool

Descripción del empleo

AbbVie in Argentina is seeking an experienced clinical research professional to advance AbbVie's pipeline by focusing on site engagement, protocol adherence and data integrity across investigator sites in Buenos Aires.

You will monitor trial conduct, ensure patient safety, provide training to site staff and collaborate with cross-functional teams to drive study execution in a compliant, efficient manner. Strong knowledge of GCP/ICH and local regulatory requirements is essential.