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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. This role involves managing site relationships to ensure clinical 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 to ensure efficient clinical trial management.
- Foster internal and external customer relationships to ensure efficient, timely, and productive project delivery.
- Collaborate with In-house Clinical Research Associates and Regulatory Start Up Associates to prepare essential site documents and support regulatory submissions.
- Understand local and international regulatory requirements relevant to specific clinical trials in collaboration with the Regulatory Start-up Team.
- Ensure participant recruitment targets are met by driving engagement initiatives and developing site-specific recruitment plans.
- Monitor investigational sites according to ICH GCP, including all visit types (Selection, Initiation, Monitoring, Close Out), unblinded pharmacy visits, and co-monitoring visits, conducted either onsite or remotely.
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 working 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
- Clinical trial monitoring
- ICH GCP compliance
- Regulatory requirements
- Site relationship management
- Participant recruitment
- Data verification
- Time management
- Attention to detail
- Teamwork
- Computer literacy
Location
- Adelaide
Work Type
- Hybrid
- Flexible working hours
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 options
- Paid parental leave for both parents
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
- NovoLife 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).
- Fosters an environment that reflects the life-changing work they 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.
- Employees are at the heart of their success.
- Offers trust, flexibility, and autonomy.
- Empowers team members to create an effective work-life balance.
- Provides access to mentorship opportunities, professional development programs, and a dynamic community.
- Has advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model.
- Offers employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture.
- Works with clients on the cutting-edge of life sciences.
- Works alongside 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.
Equal Opportunity
- Committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
- Looking for people who identify as LGBTIQ+, have a disability or have caring responsibilities.
- Circle Back Initiative Employer and commit to respond to every application.