Regulatory Affairs & Submissions Officer

Garvan Institute of Medical Research brings together world leading scientists and clinicians collaborating locally and globally to advance our understanding of disease particularly cancer autoimmunity and genetic disorders. Garvan is a global leader in fundamental biomedical research and its translation. Our mission is to make discoveries that will improve health for all.

THE OPPORTUNITY

The Regulatory Affairs and Submissions Officer is part of the well established NSW Early Phase Clinical Trials Alliance (NECTA). The position will primarily involve managing clinical trials Ethics and RGO submissions for members sites and clinical trials units across our collaboration early phase network. The role will also involve supporting clinical research correspondence and notifications multiple study management communication with internal and external stakeholders and administrative support for the network of clinical trials sites.

Salary: $% super (Prorated $80677.20 12% super)

Employment Type: Part time position for one year (22.8 hours per week)

SNAPSHOT OF BENEFITS

• Generous salary packaging to save you income tax on your wages thereby boosting your monthly take home pay (max. $15900 general expenses $2650 meals/accom)

• Ample opportunities for on-going training and development

• Stimulating diverse and highly international research environment

• Flexible work arrangements e.g. start / finish times

• 18 weeks paid parental leave for both parents including paid superannuation

• A range of additional leave types to meet your personal needs including cultural leave conference leave community service and study leave

• Discounted Health Insurance

• Lifestyle discounts with our community partners

WHAT YOU WILL DO

The key responsibilities include:

• Preparation of Ethics committee submissions CTN applications and other required regulatory documentation.

• Regularly update relevant site Research Governance Offices as mandated by regulations.

• Liaise with the HREC and Research Governance Offices as required to ensure smooth operation of research projects

• Promote the vision and goals of NECTA.

• Liaise with clinical research associates data managers research contract organisations and pharmaceutical sponsors for data query resolution and source document verification.

• Liaise with other health professionals at NECTA sites on the conduct of trials if required.

• Establish and maintain effective communication with medical nursing and other technical and research staff as well as clinical trial sponsors

• Assist the NECTA manager with the budget negotiation contracting and other management tasks as required.

ABOUT YOU

The key skills and experience include:

• Experience in the regulatory requirements of clinical trials including HREC and Governance submissions CTN submissions and mandatory reporting

• Appropriate tertiary qualification in science or health related discipline or demonstrated relevant equivalent professional experience in the Health Service environment.

• Experience in clinical research with a significant component of experience in clinical trial procedures.

• Knowledge and experience in the disciplines essential for clinical research including secure data management participant trial data collection participant organisational skills ability to rapidly master new concepts and skills detailed knowledge of HREC and RGO submissions.

• Excellent written and verbal communication skills and proficiency in a range of computer application systems including Microsoft Office spreadsheets and databases and electronic data capture systems.

• Ability to rapidly master new concepts and skills.

• Strong organisational skills the ability to work independently and as part of a team adhere to documented procedures

• The ability to adhere to professional standards and understanding of clinical trial compliance requirements in line with Good Clinical Practice (GCP).

ABOUT GARVAN

Garvan Institute of Medical Research is an independent Medical Research Institute (MRI) in Sydney delivering scientific and clinical impact on a global basis and in partnership with organisations that share our vision. We are proud to be one of Australias largest and most highly regarded MRIs.

Our vision is global leadership in discoveries to impact and our enduring purpose is to impact human health by harnessing information encoded in our genome.

We seek to see our world-class discovery research achieve life-changing impacts not only for individual patients with rare diseases but for the many thousands affected by complex common disease.

Garvan promotes a diverse workplace and is committed to the principles of equity diversity inclusion and belonging. We are always looking for culture add not culture fit and are building diverse teams with great sets of complementary styles and skills to help deliver our important work effectively.

HOW TO APPLY

To apply for this position please submit your application with a CV and cover letter as one document stating why you are interested in this role. We are reviewing applications as they are received. If you think youre the right person for this role wed love to hear how your capabilities achievements and experience set you apart. Only applicants with full working rights in Australia are eligible to apply for this role.