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About the Role
The Clinical Research Associate (CRA) is responsible for ensuring the rights and wellbeing of trial participants are protected and that trial data is accurate, complete, and verifiable. The CRA serves as the primary contact between investigational sites, Novotech, and the Sponsor, acting as a site relationship manager to ensure clinical trials comply with ICH GCP guidelines, regulatory requirements, and company SOPs. This role is based in Sydney and offers hybrid working arrangements and flexible hours.
Responsibilities
- Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to ensure efficient 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 regulatory submission processes.
- 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 by driving recruitment initiatives and preparing site-specific recruitment plans.
- Monitor investigational sites according to ICH GCP, including all visit types (Site Selection, Initiation, Monitoring, Close Out), unblinded pharmacy visits, and co-monitoring visits, either onsite or remotely as per the Clinical Management Plan (CMP).
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.
- CRA II: minimum of 6 months of CRA independent monitoring experience.
- CRA III: 2+ years of CRA independent monitoring experience.
- Full unrestricted working rights in Australia.
- Cannot provide sponsorship for this role.
Skills
- ICH GCP guidelines
- Local and global regulatory requirements
- Novotech/Client SOPs
- Time management
- Attention to detail
- Teamwork
- Computer literacy
Location
- Sydney
- Australia
Work Type
- Hybrid
- Full time
- Employee
- Regular
Experience Level
- CRA II: minimum of 6 months of CRA independent monitoring experience
- CRA III: 2+ years of CRA independent monitoring experience
Education Level
- Graduate in a clinical or life sciences-related field
Benefits
- Flexible working hours
- NovoLife, our flexible benefits framework
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Novotech is a globally recognized leader in clinical research and scientific advisory services.
- Award-winning workplace culture that values ambition, innovation, and growth.
- Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE).
- Fostering an environment that reflects the life-changing work we do.
- Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
- Unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
- Offers trust, flexibility, and autonomy through programs like NovoLife.
- Empowers team members to create an effective work-life balance.
- Provides access to mentorship opportunities, professional development programs, and a dynamic community.
- Offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
- Advanced therapeutic and regulatory expertise.
- Ability to execute across markets.
- Client-centric service model.
- Trusted, long-term partner.
- Accelerated path to bring life-changing advances to market.
- Opportunity to develop careers by joining a diverse and supportive global organization with a collaborative culture.
- Working with clients on the cutting-edge of life sciences.
- Empowered teams with a shared commitment to success.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.