The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and that the reported trial data are accurate, complete, and verifiable from the source documents. The CRA serves as the main contact between the Investigational Sites, Novotech, and the sponsor, managing site relationships and ensuring trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

This role will be based in Sydney and we offer hybrid working arrangements and full flexibility in working hours to support a healthy work‑life balance.

Minimum Qualifications & Experience

- Graduate in a clinical or life sciences‑related field. Relevant experience or qualifications in allied professions may also be considered.
- Must have valuable time management skills, attention to detail, ability to work well in a team, and be computer literate.
- CRA II: minimum of 6 months independent monitoring experience.
- CRA III: 2 + years independent monitoring experience.
- S‑CRA: minimum of 4 years monitoring experience, preferably within oncology.

You must have full unrestricted working rights in Australia to be considered for this role. We unfortunately cannot provide sponsorship.

Responsibilities

- CRA’s primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure efficient, expedited, and smooth management of clinical trials.




- Foster internal and external customer relationships to ensure focus on efficient, timely, and productive project delivery as per study requirements and timelines.
- Collaborate with the In‑house Clinical Research Associate (IHCRA) and Regulatory Start‑Up Associate (RSA) to prepare site essential documents and support ethics and regulatory submission and approval processes as needed.
- In collaboration with the Regulatory Start‑up (RSU) team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
- Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site‑specific recruitment plans and update as required.
- Monitor investigational sites as per ICH GCP, covering all monitoring visit types across all phases of a clinical trial (Site Selection, Site Initiation, Site Monitoring, Site Close‑Out, unblinded pharmacy visits, and co‑monitoring visits). Visits can be conducted either onsite or remotely as per CMP.

Novotech is committed to creating an inclusive work environment where everyone is treated fairly and with respect. Benefits include flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development programmes.

We welcome candidates who identify as LGBTIQ+, have a disability, or have caring responsibilities, and who are passionate about working in clinical research and biotech.

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📌 Clinical Research Associate - NSW (City of Sydney)
🏢 Novotech
📍 City of Sydney