Clinical Trial Quality Specialist

Working with Australasian Gastro-Intestinal Trial Group we are seeking a Clinical Trial Quality Specialist which is a newly created role

Working in partnership with Non For Profit Australasian Gastro-Intestinal Trial Group (AGITG) we are seeking a Clinical Trial Quality Specialist which is a newly created opportunity .
Established in 1991 AGITG is a recognized leader for conducting high-quality local and multinational research across the Clinical Trial paradigm. Working in collaboration with strategic partners, they operate in countries including Australia, New Zealand, United Kingdom, Europe, Asia and North America.
The focus of the organization is to create a world free from Gastrointestinal cancer and ensure existing patients are the focus of the ongoing research and discovery which will lead to cures.
Benefits on offer:

• Competitive market salary and benefits.
• Generous salary packaging benefits.
• Flexible working arrangements - onsite, hybrid or work-from-home.
• Being part of a supportive team and engaged membership, making an impact on GI cancer health outcomes.
• Work collaboratively with Clinical Trial investigators.
• AGITG is an equal opportunity employer and is committed to fostering an inclusive and diverse work environment. We encourage individuals of all backgrounds to apply.

This is the perfect opportunity to partake in the Group’s continued growth. Reporting to the Head of Research Operations and working alongside the Clinical Portfolio Lead – Operations the focus of the role will be to implement and maintain a Quality Management System for Phase I-IV Clinical Trials. The role will also focus on adopting and endorsing a quality management focus and culture across the wider organization.
Auditing and inspections, documentation review, risk assessment, training and mentoring, vendor oversight and data integrity will be key responsibilities and duties associated with this role.
Required experience:
Essential

1. Bachelor’s degree or equivalent work experience in a discipline relevant to Clinical Trial operations and working exposure to Clinical Trial Quality management.|
2. Certification in Clinical Research (e.g., ACRP, SoCRA) and/or Quality Assurance (e.g., ASQ) preferred.
3. Minimum of 2 years of experience working Clinical Trial Quality management.
4. Prior experience in Clinical Trial operations, e.g. CRA, monitor, project management, site manager.
5. Working knowledge of national and international regulations, guidelines and best practice related to the conduct of Phase I to IV Clinical Trials.
6. Strong computer literacy with knowledge of Clinical Trials software and MS Office suite.
7. Undertake travel, domestically and on occasion internationally to fulfil the requirements of the role.

Desirable

1. Previous experience of working in R&D, Pharmaceutical or Commercial Research Organisation (CRO) environments or similar.
2. Previous experience in training of Clinical Trial staff