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About the Role
The Clinical Research Associate (CRA) is responsible for protecting trial participant rights and well-being, ensuring data accuracy, and serving as the primary contact between investigational sites, Novotech, and sponsors. The CRA acts as a site relationship manager, ensuring trials comply with ICH GCP guidelines, regulatory requirements, and company SOPs.
Responsibilities
- Build relationships with Principal Investigators, study coordinators, pharmacists, and relevant site trial personnel for efficient clinical trial management.
- Foster internal and external customer relationships to ensure efficient, timely, and productive project delivery.
- Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA) to prepare essential site documents and support ethics and regulatory submissions.
- Understand local and international regulatory requirements relevant to specific clinical trials in collaboration with the Regulatory Start-up (RSU) Team.
- Ensure participant recruitment meets site targets, drive recruitment initiatives, and prepare/update site-specific recruitment plans.
- Monitor investigational sites according to ICH GCP, including site selection, initiation, monitoring, close-out visits, unblinded pharmacy visits, and co-monitoring visits.
Requirements
- 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.
- Computer literacy.
- Experience in the research, pharmaceutical industry, or a related field.
- SCRA: minimum of 3 years of CRA independent monitoring experience, preferably within Oncology.
- Full unrestricted working rights in Australia.
- Cannot provide sponsorship for this role.
Skills
- Time management
- Attention to detail
- Teamwork
- Computer literacy
- Clinical trial monitoring
- Regulatory compliance
- Relationship management
Location
- Sydney
Work Type
- Hybrid working arrangements
- Full flexibility in working hours
Experience Level
- Minimum of 3 years of CRA independent monitoring experience (for SCRA)
Education Level
- Graduate in a clinical or life sciences-related field
Benefits
- Flexible benefits framework (NovoLife)
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Globally recognized leader in clinical research and scientific advisory services.
- Award-winning workplace culture valuing ambition, innovation, and growth.
- Named Employer of Choice, Great Place to Work, and Employer of Choice for Gender Equality (EOCGE).
- Over 30 offices across Asia-Pacific, the United States, and Europe.
- Focus on advancing therapies that improve patient outcomes worldwide.
- Offers mentorship opportunities and professional development programs.
- Possesses advanced therapeutic and regulatory expertise.
- Ability to execute across markets with a client-centric service model.
- Provides a trusted, long-term partnership for clients.
- Accelerates the path to market for life-changing advances.
- Offers a collaborative culture with empowered teams.
- Fosters a strategic mindset, proactive decision-making, and a culture where every voice is heard and valued.
- Provides ongoing support from senior stakeholders and the leadership team.