Job Description

About Southern Star Research Southern Star Research is a global contract research organization dedicated to advancing medical products to market. We deliver high‐quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety, and quality assurance.

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Role

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The Project Support Associate (PSA) provides essential administrative support to our clinical operations and project management teams. This development role offers a fast‐paced environment and a clear path for growth opportunities in clinical research.

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Responsibilities

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Quality Systems and Compliance

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- Conduct quality control review of data entered into systems for assigned projects
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- Work with project managers to ensure the Trial Master File is inspection ready
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- Conduct QC reviews of documents within the eTMF
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- Manage and track study level system access across a range of platforms
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- Ensure appropriate assignment and tracking of study‐specific training
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Project Tracking and Reporting

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- Support the Project Manager to maintain study‐specific trackers
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- Prepare regular project metric reports and status updates using project systems
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Project Communication

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- Actively participate in project meetings, including coordination of invitations, preparation materials, minute taking, action log maintenance, and presentation of metrics
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- Facilitate communication between project team members as required
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Project Coordination and Delivery

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- Support the project manager to develop essential document templates for assigned projects and load project plan templates into the eTMF
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- Manage, track and distribute ancillary trial supplies to and from investigational sites
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- Support site payments and invoicing
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- Assist with preparation and tracking of IRB/IEC/RA and other local submissions
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Qualifications

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- Appropriate tertiary qualifications in medical, pharmaceutical, or healthcare disciplines
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- High degree of computer literacy, including full Office 365 suite; proven capability to learn and work within other systems
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- Excellent planning and organisational skills, with the ability to work on competing projects and tight deadlines
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- Collaborative approach to work
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Benefits

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- Competitive remuneration
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- Ongoing career development opportunities during our growth phase
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- One extra day off per year (STAR day) to recharge
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Diversity, Equity, and Inclusion

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Southern Star Research is committed to fostering a safe, inclusive, and respectful workplace where everyone feels valued and empowered to contribute. We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences. We provide equal opportunities for all applicants, regardless of race, ethnicity, gender identity, sexual orientation, age, disability, or cultural background.

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📌 Project Support Associate/Senior Project Support Associate (New South Wales)
🏢 Southern Star Research
📍 New South Wales