Architect, National Clinical Trial Operations

Family Doctor Pty Ltd; Australia; Hybrid; AUD 180,000 - 260,000; Full time

Benefits offered by this job

Flexible working

Travel across network

Job summary

Family Doctor Pty Ltd in Australia is launching a greenfield clinical trials capability across its 110 GP clinics. You will design the operating model, stand up sites, train staff and create a scalable platform that supports ethics, governance and sponsor audits.

The role reports to the executive team, offering direct access to the CEO, national travel, and a unique opportunity to build a new capability from the ground up within a doctor-owned network.

Qualifications

• Substantial clinical research experience across CRO, sponsor or site environments.
• GCP certification and deep working knowledge of ICH-GCP and TGA requirements.
• Proven experience building or running quality systems and SOPs to audit standard.
• Site activation and governance experience - HREC submissions, CTN scheme, site agreements.
• A track record of training and credentialing clinical research staff.
• Experience coordinating across multiple sites or programs.

Responsibilities

• Design and implement the quality management system, SOPs and governance framework to sponsor-audit standard.
• Establish site activation across the network - ethics and governance submissions, CTN scheme requirements, site agreements, indemnity and insurance.
• Build a flagship model: a first cohort of high-capability trial sites, with a wider feeder network behind them.
• Train and credential practice staff as coordinators, and GPs as investigators and sub-investigators.
• Own delivery - recruitment performance, data quality, protocol compliance and sponsor audit outcomes.
• Specify systems requirements (CTMS/eCRF) and integrate trial workflow with our clinical software without disrupting clinic throughput.

Skills

Clinical research experience

GCP certification

ICH-GCP knowledge

TGA requirements

Quality systems

SOPs governance

Site activation

HREC submissions

Training and credentialing

Cross-site coordination

Job description

Family Doctor Pty Ltd in Australia is launching a greenfield clinical trials capability across its 110 GP clinics. You will design the operating model, stand up sites, train staff and create a scalable platform that supports ethics, governance and sponsor audits.

The role reports to the executive team, offering direct access to the CEO, national travel, and a unique opportunity to build a new capability from the ground up within a doctor-owned network.