This is a fully remote position, open to applicants in Australia.

📋 Description

• Facilitate and monitor system access for members of the project team.

• Oversee project portals and conduct quality assessments on documentation.

• Assist in the preparation, distribution, and shipment of clinical trial materials, including Investigator Site Files.

• Manage document version control and submit project documentation to the Trial Master File.

• Keep track of and maintain project-related information, including logs of medical questions and answers from sites.

• Prepare and circulate meeting minutes for sponsor, project, and internal management gatherings.

• Maintain precise records of participating sites and study personnel.

• Organize and monitor project-specific training assignments and their completion.

• Contribute to additional project and administrative tasks that support project delivery.

• Collaborate with Project Managers, Clinical Research Associates, and global study teams.

⛳️ Requirements

• A degree-level qualification or equivalent experience.

• A minimum of one year of experience in a related position.

• Proficiency in English, featuring excellent written and verbal communication abilities.

• Strong interpersonal skills with the capacity to collaborate effectively within cross-functional teams.

• Ability to work independently while also being an effective team contributor.

• Strong organizational, problem-solving, and multitasking capabilities in a fast-paced setting.

• Exceptional attention to detail and a commitment to producing high-quality work.

• Advanced proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint.

• Familiarity with and understanding of ICH, GCP, and relevant FDA or EU regulatory standards.

🏝️ Benefits

• Equal employment opportunities irrespective of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or any other class protected by applicable law.