Clinical Trial Start-up and Regulatory Associate

PRIMARY DETAIL
- Salary Package: Competitive salary, including 17% employer's superannuation and annual leave loading.
- Appointment Type: Full-time (35 hour per week), 2 year fixed term, with opportunities for flexible work options after probation.
- Location: Macquarie University (Wallumattagal Campus, North Ryde) location

The Role

Reporting to the Start Up and Regulatory Manager, you will be responsible for:

- Regulatory & Contracts Oversight_
- Advise sponsors, investigators, and clinical trial staff on regulatory frameworks, ethics, and compliance.
- Ensure adherence to University policies and human research ethics.
- Support trial start-up activities, including submissions to ethics committees, the TGA, and trial registries.
- Assist investigators with protocol review, regulatory documentation, and financial planning.
- Maintain investigator site files and track project timelines to meet trial deadlines.
- Manage and negotiate clinical trial contracts, budgets, and vendor agreements, ensuring financial accuracy and compliance.
- Oversee University reporting systems (e.g., PURE) for financial and contractual management.
- Stakeholder Engagement & Operations_
- Build relationships with Principal Investigators, Sponsors, and Clinical Research Organisations.
- Liaise with ethics and governance committees to streamline processes and timelines.
- Track and report on study start-up activities, ensuring timely execution.
- Develop training materials and mentor Start-Up & Regulatory team members.
- Comply with EEO and WHS regulations and perform additional duties as needed.

About You

You will be an enthusiastic, customer focused individual with extraordinary attention to detail and excellent communication skills. You will draw on your knowledge of clinical trials to support our clinical trials team across multiple therapeutic areas with numerous Principal Investigators.Your ability to multi-task, manage competing priorities, to identify problems and process solutions will see you succeed in this role.

About Us

The

Clinical Trials Unit (CTU)

is part of the Faculty of Medicine, Health and Human Sciences (FMHHS) at Macquarie University. FMHHS also has the Macquarie Medical School, the Macquarie University Private Hospital, and runs patient clinics, labs, imaging and a pharmacy all on campus in close proximity to support clinical trials, and support providing patients with access to state of the art treatments. The CTU undertakes sponsored and investigator initiated Phase I to IV trials across multiple therapeutic areas with multiple Principal Investigators. Our current team of over 60 staff (managing over 160 trials) are a close knit inclusive team with a supportive culture that values team work and innovation.

Macquarie is a university engaged with the real and often complex problems and opportunities that define our lives. Since our foundation 54 years ago, we have aspired to be a different type of university. Over the years, we’ve grown to become the centre of a vibrant local and global community.

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To Apply

To be considered for this position, applicants must address the selection criteria in a separate document and upload them along with a copy of your resume.- Degree in life sciences, health and/or significant relevant experience in clinical trials.- Extensive experience working in clinical trials including ethics submissions, budget and contract development and an understanding of clinical study start up requirements and activities.- Expert knowledge of the regulatory framework around clinical trials including the National Statement on Ethical Conduct in Human Research, ICH-GCP and relevant privacy and therapeutic goods legislation- Consulting skills and the ability to negotiate and influence start-up and regulatory outcomes- Excellent communication skills, both written and verbal, including a track record of tact and discretion in handling sensitive and confidential issues- Excellent attention to detail and accuracy in producing contracts and ethics submissions- Experience developing and implementing processes within a tightly regulated industry- Well-developed computer skills in database management, MS Word, Excel, PowerPoint and web-based research.- Building and managing relationships with key stakeholders- Problem-solving & analytical skills and an ability to manage multiple priorities, deadlines, and regulatory requirements.
- Note_: This position requires a criminal history, working with children, _immunisations/vaccinations_ (Category A) and qualification checks._

Specific Role Enquiries: Gabriel Quinlan, Clinical Trial Start Up and Regulatory Manager, at


General Recruitment Enquiries: Please contact Mirna Alaaiddin, Talent Acquisition Officer, at


Applications Close: Monday 10th March 2025 at 11:59PM (AEDT)

Applications Close:
10/03/2025 11:59 PM

Diversity and Inclusion
- Innovation and ingenuity thrive at Macquarie University when diversity, equity and inclus