Clinical Research Associate (CRA) - Medical Devices
Ascend Clinical is seeking a
Clinical Research Associate (CRA)
to join our dynamic team in a full-time capacity, based in Macquarie Park, NSW. As a Clinical Research Associate, you will play a vital role in the execution and management of clinical research trials, ensuring the highest standards of data integrity, regulatory compliance, and participant safety. This position is central to our mission of advancing medical research and bringing creative treatments to patients. You will work directly with clinical trial sites, investigators, and our core research team to monitor trial progress and maintain the quality of our clinical research operations.
Key responsibilities
Monitor clinical trial sites to ensure adherence to protocol requirements, Good Clinical Practice (GCP) guidelines, and regulatory requirements
Conduct comprehensive site visits and inspections to verify data accuracy, completeness, and traceability in trial documentation
Review case report forms (CRFs) and source documentation to identify discrepancies and ensure regulatory compliance
Liaise with site staff, principal investigators, and research coordinators to communicate protocol amendments, clarifications, and study updates
Maintain detailed records of all site monitoring activities and prepare monitoring visit reports
Identify and upscale protocol violations, serious adverse events, and safety concerns to the study team and regulatory bodies as appropriate
Support recruitment and informed consent processes, ensuring participant rights and safety are protected




Maintain professional relationships with trial sites and serve as a key point of contact for on-site queries
Contribute to the preparation of regulatory submissions and trial documentation
Participate in ongoing training and professional development in clinical research methodologies and regulations
What we're looking for
Tertiary qualification in life sciences, nursing, pharmacy, allied health, or a related healthcare discipline
Minimum 2-3 years of experience in clinical research, with demonstrated experience in monitoring
medical device studies
.
Comprehensive knowledge of Good Clinical Practice (GCP) guidelines, ICH guidelines, and relevant regulatory frameworks
Strong understanding of clinical trial protocols and case report form (CRF) completion requirements
Ability to travel nationally on a semi regular basis - free airline club mmebership
Excellent attention to detail and organisational skills with the ability to manage multiple trials simultaneously
Outstanding communication and interpersonal skills, with the ability to build and maintain professional relationships
Proficiency in clinical trial management systems and data management software; experience with electronic data capture (EDC) systems is advantageous




Ability to work independently and as part of a collaborative team in a fast-paced environment
Strong problem-solving capabilities and a proactive approach to identifying and resolving issues
Professional certification or formal training in GCP (e.g., ACRP or SOCRA certification) is preferred
Knowledge of therapeutic areas such as oncology, cardiology, immunology, or neurology is advantageous
What we offer
At Ascend Clinical, we invest in our people and foster an environment where professional growth and personal wellbeing are paramount. We offer highly a highly competitive salary, career development and work-life balance. The trifecta for workplace success.
About us
Ascend Clinical is a leading clinical research organisation committed to advancing medical science and improving patient outcomes through rigorous, ethical clinical research. With a focus on delivering high-quality trial management, regulatory expertise, and site support, we partner with pharmaceutical companies, biotechnology firms, and academic institutions to bring innovative treatments to patients worldwide. Our team comprises experienced clinical research professionals dedicated to maintaining the highest standards of scientific integrity, participant safety, and regulatory compliance. We pride ourselves on our collaborative approach, industry expertise, and commitment to driving innovation in clinical research. At Ascend Clinical, we believe that the quality of our work directly impacts patients' lives, and we are passionate about contributing to medical advancement.
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📌 Clinical Research Associate (Cra) (Sydney)
🏢 Ascend Clinical
📍 Sydney