At a Glance
- Tasks: Manage clinical trials, ensuring participant rights and data accuracy.
- Company: Leading clinical research organisation based in Sydney.
- Benefits: Hybrid work options, flexible hours, and a focus on work-life balance.
- Other info: Exciting opportunities for career growth in a supportive environment.
- Why this job: Make a real difference in healthcare while building valuable relationships.
- Qualifications: Graduate in clinical or life sciences; relevant experience preferred.
The predicted salary is between 75600 - 92400 $ per year.
The Clinical Research Associate (CRA) 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 the source documents. The CRA is the primary contact between the Investigational Sites, Novotech and Sponsor. Key responsibilities include:
- Site relationship management to ensure clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
- Building relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure efficient management of clinical trials.
- Fostering internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
- Collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA) to prepare site essential documents and support the ethics and regulatory submission and approval processes.
- Understanding the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
- Ensuring recruitment of participants as per the site target and driving site recruitment and engagement initiatives.
- Monitoring investigational sites as per ICH GCP, including all monitoring visit types across all phases of a clinical trial.
Minimum Qualifications & Experience:
- Graduate in a clinical or life sciences-related field.
- Relevant experience/qualifications in allied professions may also be considered.
- Good time management skills, attention to detail, ability to work well in a team, and computer literacy.
- For CRA II: minimum of 6 months of CRA independent monitoring experience.
- For CRA III: 2+ years of CRA independent monitoring experience.
- Must have full unrestricted working rights in Australia.
This role will be based in Sydney, offering hybrid working arrangements and full flexibility in working hours to ensure work-life balance.
Clinical Research Associate II/III – NSW in Sydney employer: Novotech
Novotech is an exceptional employer that fosters a dynamic and collaborative work culture, perfect for those passionate about advancing their careers in toxicology and regulatory affairs. Located in Australia, we offer our employees comprehensive growth opportunities, competitive benefits, and the chance to work alongside industry experts on cutting-edge projects in clinical trials. Join us to make a meaningful impact in the field while enjoying a supportive environment that values innovation and professional development.
