The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.

Responsibilities:

- Support the clinical team’s inhouse activities on assigned projects.
- Coordinate and maintain clinical study documentation in the Trial Master Files (TMF), including tracking documents, preparing for internal/external audits, conducting routine QC reviews and final reconciliation, in accordance with ICH GCP and Novotech (or client) SOPs.
- Support the clinical team in essential document development, collection and management processes including translations, following Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
- Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant teams to update and maintain site milestones, subject tracking and PISCFs, ensuring data accuracy and completeness.
- Create Investigator Site Files, coordinate ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies) according to the study’s logistical requirements. Ensure safe storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
- May assist CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
- May assist with IRB submissions (safety reporting: SUSARs, line listings, DSUR, including site communication, CSR submission) and tracker management during project maintenance and closeout.

Minimum Qualifications & Experience:





- Relevant experience/qualifications in Life Sciences or related field or administration. Experience in the pharmaceutical, CRO or healthcare industry is advantageous.
- Entry to less than 2 years’ experience as inhouse CRA or relevant roles.

Novotech is committed to equal prospect employment and fostering an inclusive work environment where everyone is treated with fairness and respect.

Our team members are passionate about clinical research and biotech. We support flexible working options and development programs to help team members balance work with other priorities.

About Us

Novotech is a global full-service clinical Contract Research Organization (CRO).

Novotech is a globally recognized leader in clinical research and advisory services, with an award-winning workplace culture that values ambition, innovation, and growth. We have a growing network of offices across Asia-Pacific, the United States, and Europe to advance therapies that improve patient outcomes worldwide.

About the Team

Novotech combines advanced therapeutic and regulatory expertise with a client-centric service model to deliver trusted, long-term partnership and accelerated paths to bring life-changing advances to market. You will work with a diverse and collaborative global team, alongside empowered colleagues committed to success.

- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership.

Job Info

- Job Identification: 4201
- Posting Date: 07/13/2026
- Job Schedule: Full time
- Locations: Level 19, 66 Goulburn Street, Sydney, NSW 2000, AU

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📌 Inhouse Clinical Research Associate (Australia)
🏢 Life Sciences WA
📍 Australia