Study Start Up Associate

Study Start-Up Associate (II/III)

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.

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.

Job Overview

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.

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.

Key Responsibilities

• 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.
• Coordinate and manage regulatory submissions to Australia/New Zealand for IP release and variations as applicable during the project.
• Assist with the preparation and review of essential clinical trial documents such as Informed Consent Forms (ICFs) and site-specific agreements.
• Reviews on IP labels to ensure compliance with regulatory requirements.
• Collaborate with sites to ensure timely collection and approval of regulatory documents for IP Release and Site Activation
• Track timelines, identifying and addressing potential delays or obstacles.
• Ensure compliance with GCP, regulatory guidelines, and internal processes throughout the start-up phase.
• Work closely with project managers, clinical operations teams, and other Accelagen operational departments to ensure smooth project initiation.

Qualifications and skills

• Bachelor’s degree in Life Sciences or a related field (or equivalent work experience).
• At least 1-2 years of experience in study start-up or clinical trial coordination, preferably within a CRO or pharmaceutical company.
• Understanding of National Statement, NHMRC Guidelines, TGA Guidelines, Good Clinical Practice (GCP) and ICH guidelines.
• Strong communication and organisational skills with the ability to manage multiple studies, priorities and deadlines.
• Detail-oriented with strong problem-solving abilities.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with a Clinical Trial Management Systems (CTMS).
• Ability to work independently and in a team-oriented, collaborative environment.

Why Join Us

• Opportunity to work with a dynamic, innovative team in a fast-paced, growing industry.
• Collaborative, supportive work environment where employees are valued.
• Flexible work environment, with hybrid working model.
• Company growth creating exciting opportunities to develop your career
• Wellness day - enjoy 4 additional paid days off each year (one per quarter) to rest, recharge, and prioritise your wellbeing
• Birthday Leave - celebrate your special day with a day off, on us!
• Referral bonus - know someone great...get rewarded for the intro!

Diversity, Equity and Inclusion

Accelagen is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences.

How to Apply

Interested candidates should submit a resume and cover letter detailing their relevant experience for the Study Start-Up Associate role at ***email_hidden***