"Senior Ethics and Regulatory Officer"

•  492635
•  19-31 Dickson Road, Health Hub Morayfield, QLD, Australia, 4506
•  32 Cordelia Street, UniSC SouthBank, QLD, Australia, 4101
•  90 Sippy Downs Drive, UniSC Sunshine Coast, QLD, Australia, 4556
•  Clinical Trials
•  Professional Level 6
•  Full-Time
• UniSC Clinical Trials, Sunshine Coast Campus, Sippy Downs or the Health Hub Morayfield or Southbank campus, South Brisbane
• Level 6, $90,038 - $97,437 p.a., plus up to 17% employer superannuation
• Full-time, fixed term appointment for three years

The Opportunity

In this role you will provides specialist administrative support and your technical expertise in the ongoing management, preparation, submission and compliance of ethics and governance aspects of clinical trials projects across the UniSC Clinical Trials network.

For more information on UniSC Clinical Trials, please visit us online: UniSC Clinical Trials

You will

• provide specialist advice - requiring detailed knowledge of ICH Good Clinical Practice guidelines and applicable regulations – and high-level admin support to maintain ethics and regulatory compliance of studies from start-up through to closeout, and across the UniSC CT network;
• administration of safety monitoring and reporting and serious breach reporting, per the NHMRC guidance and internal SOPs;
• supervise staff encountering submissions of a complex nature, example, early phase studies, challenge studies, studies following complex designs; and
• prepare complex correspondence to the HREC and Institution where guidance or advice is sought.

About you

You will possess excellent communication and interpersonal skills, including a professional, and positive demeanour. You will enjoy showcasing your ability to multitask and pride yourself on your capability to maintain confidentiality and high levels of accuracy when dealing with client information/data. Additionally, you will thrive working as part of a multidisciplinary team, where you can exercise your sound judgement, take initiative and problem solve to deliver successful outcomes.

You will possess:

• completion of a relevant tertiary qualification in Health Science/Bio-Medicine with subsequent relevant experience or extensive experience with specialist expertise or an alternate equivalent combination of relevant experience and/or education/training;
• comprehensive knowledge of ICH Good Clinical Practice and applicable regulations, policies and guidelines;
• sound knowledge of the clinical trials regulatory and ethics landscape in Australia and a broad understanding of the regulatory frameworks internationally;
• high level computing skills (including databases, clinical trial electronic data entry, Microsoft Word and Excel); and
• comprehensive understanding of the privacy principles governing health information.

UniSC is an equal opportunity employer, committed to diversity and inclusion. We encourage applications from all backgrounds, including those with disabilities, women in STEM, First Nations Peoples, and individuals of diverse cultures, genders, abilities, and experiences. We value achievement relative to opportunity and encourage your commentary on your achievements in this context. For additional support during the application process, please contact us at unisc-careers@usc.edu.au or call +61 7 5430 2830.

Position Description: 6961 Senior Ethics and Regulatory Officer L6

UniSC values a diverse and talented workforce and invites applications from candidates who already have legal work rights in Australia.

All applications must be lodged through the Careers at UniSC website.

UniSC does not accept unsolicited applications. For agency inquiries, contact unisc-careers@usc.edu.au

Applications for this position close midnight, Wednesday, 28 August 2024.

Your completed application must include:

• a resume, and a response to selection criteria. Noting that within the application form, we will request a statement addressing each of the selection criteria contained within the position description.

Further information regarding how to prepare your application is available on our website: Join our team

We would love the opportunity to get to know you better, but we know it works both ways. To get to know a little more about us, visit us at: Welcome to UniSC and LinkedIn Life

Have questions or want to know more? For a confidential discussion, please contact:

Sarah Piplica

Regulatory and Start-up Manager

Telephone: 07 5456 3939

Email: spiplica@usc.edu.au

Discover UniSC

We're all about doing work that matters, connecting with great people, and being part of an incredible journey. We’re not the biggest university. But we’re growing every day, and doing big things. Like ground-breaking research, championing sustainability, producing gold-winning athletes and award-winning alumni.

We're one of the fastest growing universities in Australia, growing to over 2,000 people across 5 campuses in South East Queensland.

Teaching excellence is at the heart of what we do, and our commitment to sustainability is integrated into our teaching, research, and daily operations. Our research tackles the most pressing challenges of our time, with 26 research fields ranked at or above world standard according to the Excellence in Research for Australia Rankings. At UniSC you will have the opportunity to contribute to the educational landscape for future generations.

We foster a collaborative and supportive environment, encouraging continuous professional development and providing resources to enhance your career. We recognise and value the contributions of each team member to our culture and success. We're not afraid to be different, and we're looking for people who share our values and want to be part of a team that is working together to improve our local and global challenges.

Our Culture & Benefits:

• Our collaborative, passionate and welcoming culture is what really sets us apart.
• Modern teaching & research facilities.
• Professional development and career pathway opportunities.
• We are a proud recipient of the prestigious Athena SWAN Bronze Award, granted as part of the Science in Australia Gender Equity (SAGE) initiative.
• Flexible work arrangements & generous leave options.
• Salary packing options + 17% Super.
• EAP, fitness passport & discounted private health.