Benefits
- Competitive salary package with performance-based incentives.
- Dedicated FSP model offering long-term sponsor exposure.
- Flexible working arrangements with a combination of site and office-based activities.
- Career development opportunities within an established global CRO.
About the Company Join a leading Contract Research Organisation (CRO) with an established presence across Australia and the broader Asia-Pacific region. Partnering with pharmaceutical and biotechnology companies, the organisation delivers high-quality clinical research services across a diverse range of therapeutic areas.
With a strong reputation for operational excellence and continued investment in its people, the business offers an environment where experienced clinical research professionals can further develop their expertise while contributing to creative clinical development programs.
About the Opportunity An opportunity exists for an experienced Senior Clinical Research Associate (FSP) to join a growing clinical operations team based in Melbourne. Working within a dedicated Functional Service Provider (FSP) model, you will support clinical trial delivery for an established pharmaceutical sponsor, taking ownership of monitoring activities and building strong relationships with investigative sites.
This position offers the opportunity to work autonomously while benefiting from the infrastructure and career development pathways of an established CRO. You will play an important role in maintaining study quality, supporting site performance, and ensuring clinical trials progress in accordance with regulatory requirements.
Duties
- Conduct site selection, initiation, routine monitoring, and close-out visits across assigned clinical studies.
- Build and maintain effective relationships with investigators and site personnel to support study delivery.
- Monitor site performance, participant recruitment, and adherence to study protocols.
- Review clinical trial data and essential documentation to ensure accuracy and regulatory compliance.
- Provide guidance and training to investigative sites on study procedures and operational requirements.
- Identify and resolve site-related challenges, escalating quality or operational concerns where appropriate.
- Prepare monitoring reports and maintain accurate documentation within electronic trial management systems.
- Collaborate with sponsor representatives and internal clinical operations teams to achieve study milestones.
- Support site readiness for audits, inspections, and other quality assurance activities.
Skills and Experience
- Minimum four years of independent clinical trial monitoring experience is essential.
- Previous experience as a Senior Clinical Research Associate within a CRO or pharmaceutical environment.
- Strong understanding of ICH-GCP guidelines and Australian clinical research regulations.
- Demonstrated experience independently managing investigative sites throughout the clinical trial lifecycle.
- Excellent communication and stakeholder management skills, with the ability to engage confidently with investigators and sponsor representatives.
- Strong organisational skills and ability to manage competing study priorities.
- Comfortable working autonomously within a field-based monitoring environment.
- Tertiary qualification in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline is preferred.
Culture Join a collaborative, quality-focused organisation where experienced clinical research professionals are encouraged to take ownership of their work. The team values accountability, professional development, and strong stakeholder relationships, offering the support of an established CRO alongside the autonomy of a dedicated sponsor partnership.
How to Apply
Click apply or contact Rohan Lallbeeharry – Senior Recruitment Consultant – at
[email protected] or call [+61 485 860 660](tel:+61 485 860 660) for a confidential discussion.
About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.
- Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
- Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
- Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D;, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
- Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.
📌 Senior Clinical Research Associate (FSP) (Melbourne)
🏢 Healthcare Professionals Group
📍 Melbourne