Company Description Graythan Regulatory Services (GRS) is dedicated to adding value to clients’ drug development programs by providing specialized regulatory and clinical expertise. The organization partners with pharmaceutical and biotech companies to help bring safe and effective therapies to market efficiently. GRS focuses on high-quality support across the development lifecycle, from early-stage research through clinical trials and approval.

Team members work in a collaborative environment where scientific rigor, regulatory compliance, and patient safety are central priorities.

Role Description As a Senior Clinical Research Associate at Graythan Regulatory Services, you will oversee and monitor clinical trial activities to ensure compliance with protocols, regulatory requirements, and good clinical practice. This is a casual remote role involving visits to investigational sites to perform monitoring, source data verification, site management as well as in house CRA work. You will coordinate with site staff, sponsors, and internal teams to manage study timelines, resolve issues, and maintain high-quality documentation.

Responsibilities include reviewing study protocols and regulatory documents, tracking enrollment and data quality,



preparing monitoring reports, and contributing to risk assessment and mitigation strategies.

Qualifications

- Solid clinical trial protocol knowledge and experience applying protocols in operational settings.
- Proven 15-year experience as a Clinical Research Associate, including independent monitoring and site management.
- Hands-on experience with clinical trials and clinical operations, including start-up, conduct, and close-out activities.
- Solid research skills, with the ability to interpret scientific data and regulatory guidance.
- Thorough understanding of ICH-GCP, local regulatory requirements, and ethical standards.
- Bachelor’s degree or higher in life sciences, nursing, pharmacy, or a related field.
- Excellent organizational, documentation, and time-management skills, with attention to detail.
- Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams.
- Demonstrated ability to work on-site and travel to local study sites as needed.
- Experience in mentoring or leading junior clinical research staff is an advantage.

email application to: GRS - Info

📌 Senior Clinical Research Associate (Brisbane City)
🏢 Graythan Regulatory Services
📍 Brisbane City