About Biointelect
Biointelect is an Australian full‑service Contract Research Organisation (CRO) and strategic consultancy that partners with global clients to deliver integrated clinical trials with comprehensive regulatory, development and commercialisation solutions across the life science ecosystem. Our operating model ensures our clients are supported at every stage, with deep expertise and global reach, ensuring their life science innovation can move through the development pathway with confidence.
Learn more at www.biointelect.com
About the Role
As our CRO team continues to expand, we are seeking an experienced Senior Clinical Research Associate to join our Melbourne-based team.
Working within our boutique CRO, you’ll take ownership of a portfolio of clinical trial sites across a diverse range of Australian and international studies. As Biointelect’s primary point of contact for assigned sites, you’ll build trusted relationships with investigators and site staff while delivering high-quality clinical research that supports participant safety, data integrity and successful study outcomes.
This is an opportunity to join a collaborative, high-performing team where you’ll work closely with experienced Project Managers, contribute beyond routine monitoring activities and help
deliver the high-touch, responsive service our clients value.
Key Responsibilities
- Manage clinical trial sites from study start-up through to close-out.
- Conduct site initiation, monitoring and close-out visits.
- Build trusted relationships with sponsors, investigators and site teams.
- Monitor study progress, participant safety, data quality and protocol compliance.
- Identify and manage study risks, working collaboratively with Project Managers to deliver practical solutions.
- Support ethics, regulatory and study start-up activities.
- Prepare monitoring reports and maintain accurate study documentation.
- Mentor junior team members and contribute to continuous improvement across the Clinical Affairs team.
To be successful in the role, you’ll have:
- A degree in Life Sciences, Nursing, Pharmacy or a related discipline.
- 4+ years’ independent clinical monitoring experience within a CRO, sponsor or research environment.
- Demonstrated experience independently monitoring Phase I healthy volunteer clinical trials.
- Strong knowledge of ICH-GCP and Australian clinical trial regulations.
- Excellent relationship management skills and the ability to work confidently with investigators,
sponsors and cross-functional teams.
- Sound judgement, strong organisational skills and the ability to manage competing priorities in a dynamic environment.
- Experience in oncology, rare disease or early-phase clinical trials will be highly regarded.
- Previous mentoring or Lead CRA experience will be highly regarded.
- Willingness to travel nationally as required.
Why Join Biointelect?
You’ll work alongside industry experts on cutting-edge projects that shape the future of health technology. We value innovation, strategic thinking, and a commitment to improving patient outcomes. This is a unique opportunity to build your career in a team that blends scientific rigour with commercial strategy.
You’ll join a collaborative, experienced team where quality, responsiveness and trusted client relationships are central to how we work.
If you’re passionate about life sciences and want to make an impact, we welcome your application.
Biointelect is an equal opportunity employer. All applicants will be considered for employment without attention to race, colour, religion, sex, sexual orientation, gender identity, national origin.
