Hybrid Clinical Research Associate – Perth

Novotech; Perth; Hybrid; AUD 90,000 - 120,000; Full time

Job summary

Novotech in Perth is seeking a Clinical Research Associate to protect trial participants and ensure data integrity across sites. The role offers hybrid work arrangements and flexible hours to support work-life balance, with responsibilities spanning site relationship management, regulatory submissions, and participant recruitment.

The CRA will monitor sites per ICH GCP, collaborate with IHCRA and RSA teams, and ensure compliance with local/global regulations and client SOPs, contributing to

Qualifications

• Graduate in a clinical or life sciences-related field.
• Must have strong time management, attention to detail, be able to work well in a team, and be computer literate.
• CRA II: minimum of 6 months of CRA independent monitoring experience; CRA III: 2+ years of CRA independent monitoring experience.

Responsibilities

• CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the 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.
• collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
• In collaboration with Regulatory Start-up (RSU) Team, 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 prepare site-specific recruitment plan(s) and update as required.
• Monitoring of investigational sites as per ICH GCP This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.

Skills

Time management

Attention to detail

Team player

Computer literate

Education

Graduate in clinical or life sciences-related field

Job description

Novotech in Perth is seeking a Clinical Research Associate to protect trial participants and ensure data integrity across sites. The role offers hybrid work arrangements and flexible hours to support work-life balance, with responsibilities spanning site relationship management, regulatory submissions, and participant recruitment.

The CRA will monitor sites per ICH GCP, collaborate with IHCRA and RSA teams, and ensure compliance with local/global regulations and client SOPs, contributing to