Overview
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 is the primary contact between the Investigational Sites, Novotech and the Sponsor, managing site relationships and ensuring clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
Hybrid working arrangements and full flexibility in working hours are provided to support work‑life balance.
Minimum Qualifications & Experience
* Graduate in a clinical or life sciences‑related field.
* Relevant experience/qualifications in allied professions may be considered.
* Good time management skills, attention to detail, teamwork, and computer literacy.
* Experience in the research, pharmaceutical industry or a related field per level:
o CRA II: minimum 6 months independent monitoring experience.
o CRA III: 2+ years independent monitoring experience.
o SCRA: minimum 4 years independent monitoring experience.
* Full unrestricted working rights in Australia are required; sponsorship is not available.
Responsibilities
* Build and maintain relationships with Principal Investigators, study coordinators, pharmacists and other site personnel to ensure efficient and smooth trial management.
* Foster internal and external customer relationships to support timely and productive project delivery.
* 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 submissions.
* Understand and apply local and international regulatory requirements relevant to specific clinical trials in partnership with the Regulatory Start‑up (RSU) Team.
* Ensure recruitment of participants as per site targets and drive site recruitment and engagement initiatives.
* Conduct site monitoring visits (Site Selection, Initiation, Monitoring, Close‑out, Pharmacy and Co‑monitoring) in accordance with ICH GCP, onsite or remote as per CMP.
Benefits
Novotech offers a supportive workplace with flexible working options, paid parental leave for both parents, flex leave entitlements, wellness programs, ongoing development opportunities and a commitment to an inclusive environment for all employees.
About Us
Novotech is a global full‑service clinical Contract Research Organization headquartered in Sydney, Australia with 34 offices across Asia‑Pacific, North America and Europe. With over 3,000 employees and 5,000 site partnerships, Novotech provides clinical development services across all phases of clinical trials, achieving the highest IT security and quality standards.
About the Team
Our team culture fosters partnership and collaboration, includes strategic and transactional mindsets, proactive decision making, senior stakeholder support, and a collaborative environment for career development across a diverse global organization.
Job Info
* Job Identification 3659
* Posting Date 01/07/2026, 10:11 PM
* Job Schedule Full time
* Locations Level 8, 80 Ann Street, Brisbane City, Queensland, 4000, AU
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