We are a leading, locally positioned and globally adept Clinical Research Organisation (CRO) headquartered in Australia working with innovative clients across the globe to make a tangible impact on the future of human health and wellness. With over a decade of delivered success, our experience is widely varied across the health, wellness and disease spectrum. We offer end-to-end services across Strategic Consultants, Clinical Trials, Regulatory Affairs & Biometrics.

About the Role

We are looking for a dedicated and experienced Senior Clinical Research Associate (SCRA) to join our dynamic team. As a SCRA, you will play a crucial role in the management and monitoring of clinical trial sites, ensuring the smooth operation of clinical studies from start-up through to close-out. You will work across a variety of protocols, sites, and therapeutic areas, ensuring the integrity and quality of clinical research data.

Key Responsibilities

- Conducting site selection, initiation, routine monitoring and close-out visits across Australia.
- Managing all aspects of site monitoring activities in accordance with study protocols, ICH-GCP guidelines, SOPs and regulatory requirements.
- Building and maintaining strong relationships with investigators, site staff and key stakeholders.
- Support with site set up, including assistance in preparation of HREC and RGO and governance submission, preparation of regulatory doc packages, and essential document collection and management.
- Monitoring study progress, recruitment, enrolment, data quality, query resolution and site performance.
- Managing the process of Serious Adverse Events (SAEs) and supporting safety reporting activities.
- Delivering protocol and study-specific training to site personnel and providing ongoing site support throughout the study lifecycle.
- Collaborating with cross-functional project teams to support study execution,



documentation and operational deliverables.
- Assisting with feasibility assessments, investigator identification and site selection activities.
- Mentoring and supporting junior Clinical Research Associates through coaching and co-monitoring activities.
- Provide guidance and oversight to junior CRAs through co-monitoring and mentorship.
- Strong verbal and written communication skills, with the ability to present information clearly and effectively.
- Ability to work independently, self-manage, and proactively identify and resolve issues.
- Detail-oriented with a solid understanding of clinical trial procedures and regulatory guidelines.
- Strong problem-solving skills and ability to manage complex issues.
- Effective time management and organisational skills.

Qualifications & Experience

- Degree in Life Sciences, Pharmacy, Nursing, or a related technical qualification.
- Minimum 3 years' experience on independent on-site monitoring and site management experience.
- Advanced site monitoring skills ranging from Phase 1 to phase 4.
- Excellent knowledge of ICH-GCP and SAE and regulatory reporting.
- Available to travel interstate across Australia to attend study site visits.
- Ability to work and display leadership within a project team.
- Works efficiently and effectively in a matrix environment.
- Valid Driver's License is required.

Why Join Us?

At Accelagen, we pride ourselves on creating an inclusive and supportive work environment. As a Senior CRA, you will be given the opportunity to grow and develop in the field of clinical research. If you're passionate about advancing clinical trials and have the desire to contribute to impactful Clinical research, this is the perfect opportunity for you!

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

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📌 Senior Clinical Research Associate (Melbourne)
🏢 Accelagen
📍 Melbourne