CRA III / SCRA I
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 positions for experienced Clinical Research Associates to join us.
The Clinical Research Associate III (CRA III) / SCRA I performs 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.
Responsibilities
- Conduct site and investigator feasibility activities.
- Develop study-related documents or plans under the supervision of the study Project Manager.
- For a multi-site study, oversee and lead the operations of the clinical team as the Lead CRA including development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports.
- 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.
- Perform protocol review as requested.
- 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.
- Provide guidance and mentoring to less experienced staff during co-monitoring visits and facilitating accompanied site visits.
Requirements
- Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent field.
- Current or previous experience working as a CRA within a CRO. 5 years plus for a SCRA
- Formal ICH GCP training and a working 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.
- Ability to work under pressure in a multi-disciplinary team environment.
- 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 / SCRA / Clinical Research / CRO / Clinical Trials / Sydney / NSW / Adelaide / South Australia / Melbourne / Victoria / Work from home / Remote
