Clinical Research Associate — Hybrid Trials (Melbourne/Sydney)

IQVIA; Sydney; Híbrido; AUD 70 000 - 100 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible hybrid work environment

Car and health allowances

Resumo da oferta

IQVIA in Australia seeks a Clinical Research Associate to perform site monitoring and site management to ensure studies comply with protocol, GCP/ICH, and sponsor requirements. You will support site activities across Melbourne and Sydney, operating in a hybrid work environment with regular site visits.

The role emphasizes training, communication with sites, data integrity, and regulatory tracking, with opportunities to advance across trials and locations within IQVIA's global CRO network.

Qualificações

• Requires a Bachelor's Degree in a scientific discipline or healthcare.
• Requires at least 9 months of independent on-site monitoring experience.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Proficient in MS Word, Excel and PowerPoint.
• Strong organizational and time management skills.
• Ability to build effective working relationships with teams.

Responsabilidades

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH guidelines.
• Drive subject recruitment plans aligned with project needs to enhance predictability.
• Administer protocol training to sites and maintain regular communication with site staff.
• Evaluate site practices for protocol adherence and regulatory compliance; escalate issues.
• Track regulatory submissions, approvals, recruitment, CRF completion and data queries; support start-up if needed.
• Maintain Trial Master File (TMF) and Investigator's Site File (ISF) as required by regulations.
• Document site management activities and generate visit reports and follow-up letters.

Conhecimentos

On-site monitoring

GCP/ICH knowledge

Site management

Communication

Problem solving

Formação académica

Bachelor's Degree in scientific discipline

Ferramentas

Microsoft Word

Excel

PowerPoint

Descrição da oferta de emprego

IQVIA in Australia seeks a Clinical Research Associate to perform site monitoring and site management to ensure studies comply with protocol, GCP/ICH, and sponsor requirements. You will support site activities across Melbourne and Sydney, operating in a hybrid work environment with regular site visits.

The role emphasizes training, communication with sites, data integrity, and regulatory tracking, with opportunities to advance across trials and locations within IQVIA's global CRO network.