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About the Role
As a Clinical Trial Associate, you will play a vital role in supporting the successful delivery of clinical trials by providing essential administrative and project coordination support to global project teams. Your work will help ensure critical study activities stay on track, documentation remains accurate, and project information is maintained to the highest quality standards.
Responsibilities
- Coordinate and track system access for project team members to support efficient study execution.
- Maintain project portals and perform quality checks to ensure documentation is current and accurate.
- Support the preparation, distribution, and shipment of clinical trial documentation, including Investigator Site Files.
- Manage document version control and submit project documentation to the Trial Master File.
- Track and maintain project-related information, including site medical question and answer logs.
- Prepare and distribute meeting minutes for sponsor, project, and internal management meetings.
- Maintain accurate records of participating sites and study personnel.
- Coordinate and track project-specific training assignments and completion across study teams.
- Contribute to additional project and administrative activities as needed to support project delivery.
Requirements
- Degree-level qualification or equivalent experience.
- Minimum of one year of experience in a related role.
- Proficiency in English, with excellent written and verbal communication skills.
- Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams.
- Ability to work independently while also contributing as an effective team member.
- Strong organizational, problem-solving, and multitasking skills in a fast-paced environment.
- Excellent attention to detail and commitment to producing high-quality work.
- Advanced proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
- Working knowledge and understanding of ICH, GCP, and applicable FDA or EU regulatory requirements.
Skills
- Communication skills
- Interpersonal skills
- Collaboration
- Independent work
- Teamwork
- Organizational skills
- Problem-solving
- Multitasking
- Attention to detail
- Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
- ICH
- GCP
- FDA regulatory requirements
- EU regulatory requirements
Location
- Australia
Work Type
- REMOTE
- Full-time
Experience Level
- Minimum of one year of experience in a related role
Education Level
- Degree-level qualification or equivalent experience
About the Company
- Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates, and invents.
- Our mission is to work with passion and purpose every day to improve lives.
- We believe everyone plays an important role in making a world of difference for patients and their caregivers.
- We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.
- We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
Equal Opportunity
- Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.
- We provide equal employment opportunities to all employees and applicants regardless 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 other class protected by applicable law.