CRA III / SCRA I

Avance Clinical Pty Ltd.; Australia; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Flexible work options

Birthday day off

Job summary

Avance Clinical in Australia is seeking experienced CRA III / Senior CRA I to join our expanding Australian team. The role covers evaluation, initiation, monitoring and close-out of clinical trials to ensure compliance with SOPs, ICH GCP and regulatory requirements, working within a CRO environment.

You will conduct site feasibility, develop study documents, lead multi-site operations as Lead CRA, and mentor staff during co-monitoring visits, with travel up to 50%.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, nursing or equivalent field.
• Formal CRA work experience in a CRO is expected (5+ years for SCRA).
• Must have ICH GCP training and knowledge of ICH GCP guidelines.

Responsibilities

• Conduct site and investigator feasibility activities.
• Develop study documents or plans under the supervision of the Study Project Manager.
• Lead multi-site monitoring as Lead CRA, including monitoring plan development and review of visit reports.
• Perform on-site and remote pre-study visits, initiation visits, dose witnessing visits, interim monitoring and close-out visits.
• Prepare and maintain high-quality site documentation and ensure compliance with protocol and regulatory requirements.
• Raise data queries, review CRFs and ensure timely resolution with site staff.

Skills

Communication skills

Problem solving

Teamwork under pressure

Travel readiness

Education

Bachelor’s degree in life sciences, pharmacy, nursing or equivalent field

Job description

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?

• You must have full Australian working rights to be considered