Senior/Clinical Research Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior/Clinical Research Associate based in Australia.

This role plays a critical part in the execution and oversight of clinical research studies, ensuring high standards of quality, compliance, and patient safety across investigative sites. You will act as a key liaison between study sites and clinical project teams, supporting the full lifecycle of clinical trials from start-up through close-out. The position involves hands-on monitoring of clinical activities, ensuring adherence to study protocols, regulatory requirements, and industry best practices. You will work closely with investigators and site staff to maintain data integrity and ensure smooth trial execution. The environment is highly regulated, detail-oriented, and mission-driven, with a strong focus on advancing innovative therapies in areas such as oncology and rare diseases. This role requires strong autonomy, critical thinking, and the ability to manage multiple studies across different phases. It offers meaningful impact in accelerating the development of life-changing treatments for patients.

• Oversee and manage clinical trial site activities to ensure compliance with protocols, GCP, and applicable regulatory requirements.
• Conduct site visits including initiation, monitoring (on-site and remote), qualification, and close-out visits.
• Ensure patient safety, data integrity, and high-quality study conduct across assigned sites.
• Perform ongoing review of investigator site files (ISF) and ensure alignment with the Trial Master File (TMF).
• Support site start-up activities including feasibility, ethics/IRB submissions, and regulatory documentation.
• Track study progress, maintain clinical trial management systems, and prepare accurate monitoring reports.
• Identify, document, and escalate protocol deviations, safety concerns, and site risks.
• Support investigational product (IP) accountability, including storage, dispensing, reconciliation, and compliance checks.
• Review clinical data, resolve queries, and support data management in ensuring data quality.
• Collaborate with investigators and internal teams to ensure timely resolution of issues and successful study delivery.
• Participate in investigator meetings, training sessions, and global study team discussions.
• Maintain strong communication with sites and act as a key point of contact throughout the study lifecycle.

Requirements:

• Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, or a related scientific discipline (or equivalent experience).
• Minimum of 3 years of on-site clinical monitoring experience, preferably with oncology and Phase I studies exposure.
• Strong knowledge of ICH-GCP guidelines, clinical trial processes, and regulatory requirements.
• Experience conducting site visits and managing end-to-end monitoring activities independently.
• Strong attention to detail with the ability to ensure accuracy in documentation and data review.
• Excellent communication and interpersonal skills, with the ability to build strong site relationships.
• Ability to manage multiple studies and priorities in a fast-paced, remote-enabled environment.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
• Willingness and ability to travel extensively (approximately 60–70%).
• Strong problem-solving skills, self-motivation, and ability to work both independently and in teams.

Benefits:

• Competitive compensation aligned with experience and clinical expertise.
• Comprehensive health and wellness coverage, including medical support programs.
• Paid time off, holidays, and flexible working arrangements where applicable.
• Strong professional development and training opportunities in clinical research.
• Exposure to global clinical trials in oncology and rare disease therapeutic areas.
• Travel opportunities as part of international study monitoring responsibilities.
• Collaborative, science-driven work environment focused on innovation and impact.
• Career growth opportunities within clinical operations and research leadership paths.