Clinical Trial Coordinator – Research governance

·       Come and join our dynamic clinical trial and research team!

·       A role with Healthscope means more, Come and be the difference in our patient's lives.

·       Gain access to fantastic healthscope employee benefits, discounted fitness membership, retail offerings and more!

We have an exciting opportunity for a highly motivated and skilled Clinical Trial Coordinator – Research Governance in our Clinical Trials Unit (CTU) on a part time basis at Newcastle Private Hospital (NPH).

In this role, you will be pivotal to clinical trial management within the CTU and responsible for the preparation, submission and management of ethics and regulatory documents for numerous clinical trials.

As the successful candidate, you will be highly skilled with regulatory and governance knowledge, be able to effectively engage, collaborate and communicate within the CTU team and with a wide range of stakeholders. You will manage a varied workload, demonstrating exceptional attention to detail and highly proficient computer skills.

Essential Criteria:

·       Bachelor’s degree in relevant health sciences, other allied health field OR significant practical and professional experience in the ethics, research governance and regulatory environment

·       Proven experience in a clinical research environment

·       Understanding of national and international research guidelines, including high level knowledge of Good Clinical Practice

·       Exceptional attention to detail, including proficient administrative and organisational skills

·       Effective written and verbal communication skills

·       Ability to independently solve problems and efficiently manage your own workload.

·       Excellent teamwork skills, with demonstrated ability to collaborate in small teams and with a wide range of varying stakeholders

·       Well organised and efficient, with the capacity to work under pressure

·       Commitment to customer/patient focus and quality assurance

·       Computer literacy (Microsoft outlook, word, excel, teams) and database experience

Desirable Criteria:

·       Previous experience in a cancer research or related field will be highly regarded

·       Postgraduate qualifications in clinical trials, medical governance or similar

Key responsibilities: 

·       Work closely with the Newcastle Private Hospital Clinical Trials Unit Research Manager to facilitate and drive study start-up processes through to study and site activation

·       Complete the initial study feasibility questionnaires and maintain initial correspondence with a trial sponsor

·       Act as the central reference point for NPH CTU for legal requirements of a trial, including reviewing and evaluating the initial clinical trial research agreements and budgets, establishing service agreements with required ancillary providers and overseeing study start-up activities

·       Coordinate the preparation of ethical and governance submissions (initial and ongoing) in accordance all appropriate and applicable clinical trial regulations and liaise with the NPH Research Governance Office (RGO) to obtain required approvals.

·       Generate and maintain site master files for all regulatory-related documents for NPH CTU

·       Develop and maintain NPH CTU standard operating procedures to manage unit activity metrics

·       Assist with research governance reporting to relevant stakeholders as required

·       Maintain a working knowledge of all national and international guidelines regarding clinical trials

·       Assist in the continuous improvement in research and clinical trial activities conducted at NPH CTU by providing training to NPH CTU staff as required

Application Close: 13^th May 2025

To Apply: Please click on the 'Apply' button to be taken to our online application form. Please include a cover letter and your CV along with the contact details of 2 professional referees.

If you are successful in the role, you will receive a salary based on your years of relevant experience against the relevant industrial instrument

Our commitment to quality and safety for our patients, staff and visitors is our highest priority. Applicants will be required to provide a current (12 months or less) National Police check and a NSW Working with Children’s Check, persons in patient contact roles will be required to provide proof of immunity to specified infectious diseases prior to commencement.

Why Healthscope?

When you join Healthscope, you become part of our Community of Care. Our people are at the heart of our organisation - no matter the role, every day our people make a difference to the lives of our patients and their families. As the only national private hospital operator and healthcare provider in Australia, our 42 sites are supported by our central Support Office, enabling them to provide an exceptional experience for the communities we care for.

·       Flexibility to work across one or multiple hospitals across our network.

·       Continuous professional development, education & support provided to encourage growth

We pride ourselves on working with talented, passionate and caring people to ensure our patients receive the highest quality care and experience during their stay with us.