Senior/Clinical Research Associate

Role overview

This opportunity is for a Senior/Clinical Research Associate in Australia, with applications and hiring coordination handled by a partner company. The role is central to the delivery of clinical studies, with responsibility for overseeing site performance, protecting participant safety, and maintaining compliance with clinical trial standards and regulatory expectations.

You will serve as a main connection between trial sites and the broader study team, supporting activities from study start-up to close-out. The position requires active site oversight, careful documentation review, and close collaboration with investigators and internal stakeholders to keep studies running smoothly. The work environment is highly regulated, detail-focused, and oriented toward advancing innovative therapies, including programs in oncology and rare diseases. This role suits someone who can work independently, think critically, and balance multiple studies across different phases.

Responsibilities

• Lead and coordinate site-level trial operations so that study conduct remains aligned with protocols, ICH-GCP, and applicable regulations.
• Carry out site initiation, monitoring both remotely and in person, qualification, and close-out visits.
• Protect participant safety, support reliable data collection, and uphold high-quality trial execution at assigned sites.
• Regularly examine investigator site files and confirm consistency with the Trial Master File.
• Assist with study start-up tasks such as feasibility review, ethics/IRB submissions, and preparation of regulatory documents.
• Monitor study status, maintain clinical trial management systems, and produce clear and accurate monitoring reports.
• Spot, record, and escalate protocol deviations, safety concerns, and any operational risks at the site.
• Support investigational product oversight, including storage checks, dispensing review, reconciliation, and compliance verification.
• Review clinical data, manage query resolution, and contribute to data quality efforts with the data management team.
• Work with investigators and internal teams to resolve issues promptly and support timely study delivery.
• Take part in investigator meetings, study training, and global team discussions as required.
• Maintain consistent communication with sites and act as a trusted point of contact throughout the trial lifecycle.

Requirements

• A bachelor’s qualification in Life Sciences, Healthcare, Pharmacy, or a closely related scientific area, or equivalent practical experience.
• At least 3 years of experience in on-site clinical monitoring, ideally with exposure to oncology and Phase I studies.
• Solid understanding of ICH-GCP standards, trial operations, and regulatory obligations.
• Proven ability to conduct site visits and manage end-to-end monitoring tasks independently.
• Excellent attention to detail, with the ability to check documentation and data for accuracy.
• Strong written and verbal communication skills, plus the ability to build effective relationships with site teams.
• Comfort working across multiple studies and shifting priorities in a fast-moving, remote-enabled setup.
• Good working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Willingness and capacity to travel extensively, approximately 60–70% of the time.
• Strong troubleshooting ability, self-direction, and the flexibility to work both independently and collaboratively.

Perks and benefits

• Competitive pay package matched to experience and clinical expertise.
• Comprehensive health and wellness support, including medical assistance programs.
• Paid leave, public holidays, and flexible working options where applicable.
• Learning and development opportunities tailored to clinical research careers.
• Exposure to global oncology and rare disease clinical trials.
• Travel opportunities linked to international monitoring responsibilities.
• A collaborative, science-led workplace centered on innovation and impact.
• Potential career progression across clinical operations and research leadership tracks.

Additional information

This role is advertised on behalf of a partner organization that will manage applications and the next stages of the hiring process. Selection is expected to be based on an AI-assisted matching review followed by the partner company’s internal recruitment process. Personal data submitted during application may be processed for candidate assessment and shared with the hiring employer in line with applicable data protection laws. AI tools may also support parts of the recruitment workflow, but final hiring decisions remain with human reviewers.