Clinical Research Associate (Sydney)

Clinical Research Associate (Sydney)

23 Sep
|
Ascend Clinical
|
Sydney

23 Sep

Ascend Clinical

Sydney

Ascend Clinical is seeking a Clinical Research Associate (CRA) to join our dynamic team in a full-time capacity, based in Sydney. 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 innovative 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.

We would love to hear from Research Nurses and Study Coordinators looking for a change.

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 escape 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

Minimum 5 years of experience in clinical research with experience in medical devices

Tavi experience highligh regarded

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 membership

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

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 is 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 cutting-edge 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.

Macquarie Park

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

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