Job Title: Clinical Research Associate (CRAII - CRAIII) The Clinical Research Associate (CRAII - CRAIII) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from source documents.
The CRA acts as the primary contact between Investigational Sites, Novotech, and the Sponsor.
A key responsibility is managing site relationships to ensure clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
We offer hybrid working arrangements and full flexibility in working hours to help our staff achieve 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.
Good time management skills, attention to detail, teamwork ability, and computer literacy.
Experience in the research or pharmaceutical industry or related field: CRA II: minimum of 6 months of independent monitoring experience.
CRA III: 2+ years of independent monitoring experience.
Note: Candidates must have full unrestricted working rights in Australia; sponsorship cannot be provided.
Responsibilities Build and maintain relationships with Principal Investigators, study coordinators, pharmacists, and site personnel to facilitate efficient trial management.
Foster internal and external customer relationships to ensure timely and productive project delivery.
Collaborate with the in-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA) to prepare site documents and support ethics and regulatory submissions.
Understand local and international regulatory requirements relevant to specific trials.
Ensure participant recruitment targets are met; develop and update site-specific recruitment plans.
Monitor investigational sites according to ICH GCP, including all visit types across trial phases, either onsite or remote as per CMP.
Novotech is committed to providing a great workplace, promoting gender equality, and fostering an inclusive environment.
We support flexible working options, paid parental leave, wellness programs, and ongoing development.
We welcome applicants who are passionate about clinical research and biotech, including those who identify as LGBTIQ+, have a disability, or caring responsibilities.
We are a Circle Back Initiative Employer and will respond to every application.
We look forward to contacting you regarding your application.
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