Job Description
Accelagen is a locally positioned and globally adept full-service Contract Research Organisation (CRO) headquartered in Melbourne. We partner with innovative clients across the globe to drive meaningful advancements in human health and wellness.
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With over 15 years of delivered success, our expertise spans across the health, wellness and disease spectrum. We offer end-to-end services across Strategic Consultancy, Clinical Trials, Regulatory Affairs, Biometrics, Safety and Medical monitoring and Quality assurance, helping our clients deliver smarter, faster, and more impactful outcomes.
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Job Overview
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We are looking for a highly motivated Study Start-Up Associate (SSUA) to join our growing team. In this full-time role, you will play a key part in the execution and coordination of study start-up activities across multi-centre clinical trials across different clinical research phases. The ideal candidate will be highly organised, proactive, and passionate about contributing to the clinical research industry.
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As part of the Accelagen SSUA team you will have the opportunity to collaborate with cross-functional teams to ensure the successful initiation of clinical studies while maintaining adherence to timelines, regulations, and client requirements.
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Key Responsibilities
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Coordinate and manage study start-up activities including supporting the development of applications and other documents relevant to Ethics and other submissions as per local/National requirements.
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Coordinate and manage regulatory submissions to Australia/New Zealand for IP release and variations as applicable during the project.
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Assist with the preparation and review of essential clinical trial documents such as Informed Consent Forms (ICFs) and site‐specific agreements.
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Reviews on IP labels to ensure compliance with regulatory requirements.
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Collaborate with sites to ensure timely collection and approval of regulatory documents for IP Release and Site Activation
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Track timelines,



identifying and addressing potential delays or obstacles.
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Ensure compliance with GCP, regulatory guidelines, and internal processes throughout the start‐up phase.
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Work closely with project managers, clinical operations teams, and other Accelagen operational departments to ensure smooth project initiation.
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Qualifications and skills
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Bachelor's degree in Life Sciences or a related field (or equivalent work experience).
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At least 1-2 years of experience in study start-up or clinical trial coordination, preferably within a CRO or pharmaceutical company.
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Understanding of National Statement, NHMRC Guidelines, TGA Guidelines, Valuable Clinical Practice (GCP) and ICH guidelines.
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Strong communication and organisational skills with the ability to manage multiple studies, priorities and deadlines.
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Detail‐oriented with strong problem‐solving abilities.
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Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
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Experience with a Clinical Trial Management Systems (CTMS).
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Ability to work independently and in a team‐oriented, collaborative workplace.
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Why Join Us
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Opportunity to work with a dynamic, innovative team in a fast‐paced, growing industry.
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Collaborative, supportive work environment where employees are valued.
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Flexible work environment, with hybrid working model.
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Company growth creating exciting opportunities to develop your career
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Wellness day - enjoy 4 additional paid days off each year (one per quarter) to rest, recharge, and prioritise your wellbeing
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Birthday Leave - celebrate your special day with a day off, on us!
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Referral bonus - know someone great...get rewarded for the intro!
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Diversity, Equity and Inclusion
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Accelagen is an equal‐opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences.
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📌 Study Start Up Associate (Victoria)
🏢 Accelagen
📍 Victoria