Clinical Research Associate

Ascend Clinical; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Career development

Work-life balance

Job summary

Ascend Clinical is seeking a Clinical Research Associate (CRA) to join our dynamic team in Sydney. This full-time role focuses on monitoring trials, ensuring data integrity, regulatory compliance, and participant safety, and coordinating with sites and investigators.

The ideal candidate has at least 5 years in clinical research with medical devices, strong GCP/ICH knowledge, and willingness to travel nationally. We offer a competitive salary and opportunities for professional development.

Qualifications

• Minimum 5 years of experience in clinical research with experience in medical devices.
• Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Excellent attention to detail and organizational skills.
• Ability to travel nationally on a semi-regular basis.

Responsibilities

• Monitor clinical trial sites to ensure adherence to protocol requirements, GCP guidelines, and regulatory requirements.
• Conduct site visits and inspections to verify data accuracy and traceability in trial documentation.
• Review case report forms (CRFs) and source documentation for discrepancies and compliance.
• Liaise with site staff, principal investigators, and coordinators to communicate protocol amendments and study updates.
• Prepare monitoring visit reports and maintain detailed site monitoring records.
• Identify and report protocol violations and safety concerns to the study team and regulators as appropriate.
• Support recruitment and informed consent processes, protecting participant rights and safety.
• Maintain professional relationships with trial sites as a primary on-site contact.
• Assist in regulatory submissions and trial documentation.

Job description

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 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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