Company Description Ascend Clinical is a full-service Contract Research Organization (CRO) headquartered in Australia and serving clients across Australasia. The company specializes in FDA-compliant clinical trials for early-stage medical device companies, helping sponsors achieve lower costs and high-quality data.

Ascend

Clinical maintains close working relationships with regulatory bodies such as the TGA, FDA, and others, as well as research teams in the US, Europe, Asia, and Israel. These global connections enable the organization to run multi-center trials across diverse therapeutic areas. Staffed by experienced professionals, Ascend Clinical offers sponsors strong partnerships with sites, research staff, and subject-matter specialists.

Role Description The Clinical Research Associate (CRA) will support the planning, execution, and monitoring of clinical trials to ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP). Day-to-day responsibilities include conducting site qualification, initiation, monitoring, and close-out visits; verifying source data; and ensuring accurate and timely data collection and entry. The CRA will collaborate with clinical operations, investigators, and site staff to resolve queries, manage deviations, and maintain study documentation.

The role also involves preparing reports, contributing to risk assessments,



and supporting audits and inspections as needed. This is a full-time hybrid role based in Sydney, NSW, with a combination of on-site visits and work from home.

Qualifications

- Robust understanding of clinical trial protocols and ability to apply protocol requirements to site activities and monitoring tasks.
- Experience working as a Clinical Research Associate or in a closely related clinical research role.
- Hands-on experience with clinical trials, including site monitoring, documentation review, and data verification.
- Demonstrated research skills, including data analysis, literature review, and interpretation of clinical findings.
- Knowledge of clinical operations processes, GCP, ICH guidelines, and applicable regulatory requirements.
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related field; advanced degree is an advantage.
- Excellent organizational, time-management, and problem-solving abilities, with strong attention to detail.
- Clear written and verbal communication skills and ability to collaborate effectively with diverse teams and site staff.
- Willingness and ability to travel to study sites within Australasia as required.
- Experience with medical device trials or multi-center international studies is highly beneficial.

📌 Clinical Research Associate (Sydney)
🏢 Ascend Clinical
📍 Sydney