Clinical Trial Start-up and Regulatory Assistant

Clinical Trial Start‑up and Regulatory Assistant

- Salary Package: From $86,087 per annum (HEW 5) including 17% employer's superannuation and annual leave loading.

- Appointment Type: Full‑time (35 hour per week), 2‑year fixed term appointment.

- Location: Macquarie University (Wallumattagal Campus, North Ryde) location

About the Role

Join Macquarie University's Clinical Trials Unit (CTU) as a Clinical Trial Start‑up and Regulatory Assistant and play a key role in supporting the start‑up and regulatory activities for sponsored Phase I‑IV clinical trials. In this entry‑level role, you’ll work closely with Clinical Trial Coordinators and Regulatory Associates to ensure timely ethics and governance submissions, monitor shared ethics and contracts mailboxes, maintain site documentation, and contribute to continuous improvement across regulatory and operational processes. Under the guidance of the Start‑Up & Regulatory Team Leader or Manager, you’ll support the smooth delivery of study start‑up operations and liaise with a wide range of stakeholders including sponsors, investigators, and internal governance teams.

About You

You’re a detail‑oriented, well‑organised individual with a background in life sciences, health, or clinical research, who thrives in a structured and compliance‑focused environment. You take pride in accuracy, clear communication, and teamwork.

Responsibilities

- Assisting with submissions to Ethics Committees and Faculty Governance, including regulatory file set‑up and essential documentation.

- Monitoring shared ethics and contracts inboxes, recording and flagging key amendments, and escalating issues where required.

- Maintaining accurate site files and documentation in line with Good Clinical Practice (GCP) standards.

- Liaising with sponsors, principal investigators, and vendors to support start‑up activities and ensure all documentation is complete.

- Supporting a range of operational and administrative tasks to keep projects running smoothly.

- Contributing to the improvement of start‑up and regulatory administrative processes.

About Us

The Clinical Trials Unit (CTU) sits within the Faculty of Medicine, Health and Human Sciences (FMHHS) at Macquarie University – home to an integrated health campus combining the Macquarie University Hospital, MQ Health Clinics, research labs, imaging, and a dedicated pharmacy, all co‑located to support world‑class clinical research. The CTU manages nearly 200 active clinical trials across a broad range of therapeutic areas including oncology, cardiovascular, neurological, respiratory, and surgical research. Our mission is to advance patient care through cutting‑edge clinical research and to be recognised globally as a centre of excellence in clinical trial conduct. As part of our collaborative, supportive team, you’ll enjoy access to state‑of‑the‑art facilities, flexible work options, and opportunities for professional growth within a research‑driven environment.

Essential Criteria

- Degree in life sciences, health, or a related field; or equivalent combination of relevant qualification and experience in clinical trials.

- Proficient in MS Office (Excel, PowerPoint).

- Knowledge of clinical trial processes.

- Excellent attention to detail and accuracy.

- Strong organisational skills, with the ability to work to deadlines and manage competing priorities.

- Excellent verbal and written communication skills.

- Ability to develop and maintain relationships with a range of stakeholders.

- Previous experience and knowledge of clinical trial start‑up, regulatory or contract functions.

Other Specific Requirements

- Valid Working with Children Check (please include the clearance number in the resume, if available).

- Criminal history check and qualification check.

- Work hours may vary from time to time to accommodate business needs.

How to Apply

Please submit your CV and a cover letter addressing the below criteria via our Workday Careers portal. Ensure you clearly articulate your suitability against the role requirements above.

Note: You must have valid entitlement to work in Australia for the duration of the appointment.

Applications close on Thursday 6 November 2025 at 11:59 p.m. (AEDT).

Specific Role Enquiries

Gabriel Quinlan, Clinical Trial Start‑Up and Regulatory Manager, at gabriel.quinlan@mq.edu.au.

General Recruitment Enquiries

Please contact Mirna Alaaiddin, Talent Acquisition Officer, at mirna.alaaiddin@mq.edu.au.

Note: Applications will be reviewed as they are received and we reserve the right to progress or decline an application prior to the closing date, and/or remove the advert earlier than originally advertised – early applications are encouraged.

We look forward to receiving your application and exploring the opportunity to join our dynamic team at the CTU in the Faculty of Medicine, Health and Human Sciences

A Place Where You Belong

At Macquarie, we believe diversity makes us stronger, inclusion drives our success, and belonging inspires us to do our best work. We are proud to foster a community where different backgrounds, identities, and experiences are valued, and where our people are empowered to thrive through supportive leadership, shared responsibility, and a deep commitment to genuine care and respect for our community.

Flexible Work

At Macquarie, we believe by providing flexibility in when, where and how work is done, we can support our staff to manage their personal commitments, while optimising their work performance and contributions to the University. See how we lead in flexible work to enable an outcome‑focused and inclusive workplace. To learn more about our culture and hiring process, visit our Jobs at Macquarie page.

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