At
Avance Clinical, we're helping innovative biotech and pharmaceutical companies bring life-changing therapies to patients faster. Following significant growth and new global project wins, we're expanding our team and looking for multiple CRA III’s & Senior CRA I’s to join our Australian team.
Why Join Avance Clinical?
Global Recognition: Work for the CRO recognised by Frost & Sullivan as the 2026 Global Company of the Year for excellence in biotech CRO leadership.
Work Anywhere in Australia: Enjoy genuine flexibility and autonomy with a fully remote role supported by industry-leading technology and a highly collaborative culture.
Accelerate Your Career: Join one of Australia's fastest-growing CROs, where high performers are recognised and supported to advance their careers.
Meaningful, Diverse Projects: Work with emerging biotech companies developing the next generation of therapies.
Opportunity
We have full-time permanent position for a CRA I to join us.
The Clinical Research Associate I (CRA I) perform activities associated with the evaluation, initiation, monitoring and close out of clinical trials to ensure the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.
This role would suit someone early in their clinical trial career with around 12 months experience in a GCP environment.
Responsibilities
- Conduct site and investigator feasibility activities.
- Perform all activities (preparation, execution, and follow-up) associated with onsite or remote Pre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV) and Close-out Visits (COV).
- Generate and maintain high-quality confirmation letters, site visit reports, follow-up letters and other documentation related site monitoring and management to ensure compliance with ICH GCP, study protocol and regulatory requirements.
- Monitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, meet with site personnel, and ensure procedures are conducted in accordance with the protocol and ICH GCP.
- Raise data queries in the Case Report Form (CRF) where discrepancies are identified and work with site staff to ensure timely and accurate resolution. Collect TMF documentation from site and ensure accurate and timely filing as per SOP requirements.
- Maintain effective site communication to proactively manage on-going study expectations and issues. Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required. Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
Requirements
- Bachelor’s level degree in life sciences, pharmacy, nursing, or equivalent field.
- Previous exposure to a Clinical Trials environment with around 12 months experience as a CTA, CRC, Junior CRA or similar.
- Formal ICH GCP training (desirable) and a well-developed knowledge of ICH GCP Guidelines and other applicable regulatory requirements.
- Clear understanding of the requirement to adhere strictly to client confidentiality.
- Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
- Demonstrated ability to take initiative in problem solving and in exercising good judgment.
- Awareness of Privacy Legislation as it applies to the Clinical Trial environment (desirable).
- Ability to work under pressure in a multi-disciplinary team environment.
- Willingness to work in, and be supportive of, a positive and dynamic team culture.
- Ability to travel. Moderate level of interstate travel may be required (up to 50%).
What we offer
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team that are working together on a common goal
- Flexible work options
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your birthday!
What next?
- Apply online
- You must have full Australian working rights to be considered
CRA / CRC / CTA / Clinical Research / CRO / Clinical Trials / Sydney / NSW / Adelaide / South Australia / Melbourne / Victoria / Work from home / Remote
