Sydney Hybrid CRA II/III – Clinical Research Associate

Novatech; Sydney; Hybrid; AUD 80,000 - 110,000; Full time

Job summary

Novotech in Sydney seeks a Clinical Research Associate II/III to safeguard participant wellbeing and ensure data integrity across sites. You’ll serve as the main contact between Investigational Sites, Novotech and Sponsors, supporting ICH GCP adherence, local and global regulations, and company SOPs in a hybrid, flexible work arrangement.

The role combines site relationship management with monitoring activities, including site start-up, recruitment, and ongoing quality checks across trials.

Qualifications

• Graduate in a clinical or life sciences-related field.
• Experience in research/pharmaceutical industry or related field per job level.
• Must have good time management, attention to detail, be able to work well in a team, and be computer literate.
• CRA II: minimum of 6 months CRA independent monitoring experience.
• CRA III: 2+ years of CRA independent monitoring experience.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to ensure efficient, expedited and smooth management of clinical trials.
• Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
• Collaborate with the IHCRA and RSA to prepare site essential documents, and support ethics and regulatory submission and approval processes as needed.
• With RSU, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
• Ensure recruitment of participants as per the site target; drive site recruitment and engagement initiatives and update site-specific recruitment plan(s).
• Monitor investigational sites per ICH GCP across all phases, including Site Selection, Site Initiation, Site Monitoring and Site Close Out, with onsite or remote visits.

Skills

Time management

Attention to detail

Team player

Computer literate

Education

Graduate in clinical or life sciences

Job description

Novotech in Sydney seeks a Clinical Research Associate II/III to safeguard participant wellbeing and ensure data integrity across sites. You’ll serve as the main contact between Investigational Sites, Novotech and Sponsors, supporting ICH GCP adherence, local and global regulations, and company SOPs in a hybrid, flexible work arrangement.

The role combines site relationship management with monitoring activities, including site start-up, recruitment, and ongoing quality checks across trials.