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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 the Sponsor. This role ensures clinical trials are conducted in accordance 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 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 (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 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.
• SCRA: minimum of 4 years monitoring experience, preferable within Oncology.
• Full unrestricted working rights in Australia.
• Cannot provide sponsorship for this role.

Skills

• Clinical trial management
• Relationship building
• Customer relationship management
• Regulatory compliance
• Participant recruitment
• ICH GCP
• Site selection
• Site initiation
• Site monitoring
• Site close out
• Time management
• Attention to detail
• Teamwork
• Computer literacy

Location

• Sydney

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
• SCRA: min of 4 years monitoring preferable within Oncology

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

About the Company

• Novotech is a global full-service clinical Contract Research Organization (CRO).
• Novotech is proud to offer a great workplace.
• We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
• Our team members are passionate about what we do, but we understand work is only one of the things that is important to them.
• We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
• We are a Circle Back Initiative Employer and commit to respond to every application.
• At Novotech, ambition meets opportunity.
• As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an 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), we are committed to fostering an environment that reflects the life-changing work we do.
• Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe.
• This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
• At Novotech, our employees are at the heart of our success.
• By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
• With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
• Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
• At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market.
• This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
• At Novotech you will work alongside empowered teams with a shared commitment to success.
• Strategic vs transactional mindset.
• Ability to gain insights and make proactive decisions quickly.
• Culture that fosters partnership and collaboration, where every voice is heard and valued.
• Ongoing support from senior stakeholders and leadership team.

Equal Opportunity

• We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
• We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.