Clinical Trial Start Up and Regulatory Associate

3 weeks ago

North Ryde, Australia Macquarie University Full time

PRIMARY DETAIL

Seeking a Start up Associate to provide study start-up and regulatory support for sponsored Phase I - IV clinical trial projects

THE ROLE- Salary Package: From $76,908 to $87,443 p.a. (HEW Level 5), plus 17% employer's superannuation and annual leave loading.- Appointment Type: Full time, fixed term position for 2 years.- Location: Macquarie University (Wallumattagal Campus, North Ryde)

We are seeking Start up Associates to provide study start up and regulatory support for sponsored Phase I - IV clinical trial projects. This will primarily involve assistance with contracts and study budget, ethics and regulatory submissions, and may include study feasibility and site selection for sponsored clinical trials. You will be a key link with internal and external stakeholders for the Macquarie University Clinical Trial Unit and pivotal to achieving streamlined trial start ups to maximise and support opportunities for patients to receive potentially life changing treatments.

Reporting to the Clinical Trials Start up Team Manager, this role will be responsible for supporting the fast-paced Clinical Trials team with- Macquarie University Ethics submissions of new studies, amendments to ongoing studies, annual reports, and safety reports.- Reviewing and overseeing execution of Contracts- Development and negotiation of budgets for new studies and amendments- Maintaining internal systems to support our finance team bill according to contracts- Collection of regulatory documents and setting up of our investigator site files to facilitate study start up- Supporting clinical trial feasibility assessments

To begin with the role will focus primarily on either Ethics submissions or on trial budget development but provides career opportunities for expanding and developing skills across the entire start up and regulatory and feasibility function.

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

Macquarie is the university of pioneering minds. Globally recognised as one of Australia’s leading research universities, Macquarie is a place where extraordinary new possibilities come to light. We’ve helped people to hear, introduced wireless internet technology to the world and broken through traditional boundaries by appointing the Australia’s first female vice-chancellor.

The Macquarie University

Clinical Trials Unit

in the Faculty of Medicine, Health and Human Sciences was set up in January 2013 to provide patients with opportunities to participate in the latest medical advances in cancer treatment. The Program has since continued to grow with research into a range of therapeutic areas drawing from the University’s research centres and works closely with industry sponsors and collaborative research groups to deliver timely access to cutting-edge therapies and investigations into the prevention, diagnosis and treatment of a range of diseases. The Clinical Trials Unit is strategically placed within a unique academic health environment co-located on campus, which encompasses Macquarie University Hospital (Australia’s only university-owned and operated hospital), private outpatient clinics and the medical research undertaken within the Faculty. Our team of over 60 supports patients in over 140 trials.

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.

Connect with us today


To Apply

To be considered for this position, applicants must address the selection criteria below in a separate document and upload the along with a copy of your resume.

In the cover letter please specify your preference for working primarily with Ethics submissions, or primarily with budget development and negotiation, what appeals to you about these positions, and please include how you meet the selection criteria below:
- Degree in life sciences, health, accounting or equivalent experience in clinical trials.- Computer skills including MS Office, Excel and Powerpoint.- Knowledge of the clinical trials processes.- Demonstrated attention to detail.- Building and managing relationships with key stakeholders.- Knowledge of budgets and accounting
- _(desirable)_.- Experience in clinical research, particularly in clinical trials start up procedures
- _(desirable)_.
- Note_
- : This position requires you to comply with occupational screening, assessment and vaccinations in line with Macquarie Univ

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