Senior Clinical Research Associate

Healthcare Professionals Group; Sydney; A distancia; AUD 110.000 - 140.000; Jornada completa

Descripción de la vacante

Healthcare Professionals Group is seeking a Senior CRA to deliver high-quality clinical trials across the Asia-Pacific region, ensuring safety, ethics and efficiency while building partnerships with sites and sponsors.

In an FSP model, you will conduct site selection, initiation, monitoring and close-out visits; drive patient recruitment; train site staff; perform data checks; prepare monitoring reports and upload essential documents to the eTMF.

Formación

• Bachelor's degree in a scientific discipline or health care preferred.
• 4+ years independent monitoring experience.
• Proficient in ICH-GCP and local regulations.
• Understanding of the drug development process.
• Strong written, verbal, and computer skills.
• Ability to work independently in remote environments.
• Previous Senior CRA experience.

Responsabilidades

• Operate in FSP model.
• Conduct site selection, initiation, interim monitoring and close-out visits.
• Develop and drive patient recruitment plans with sites.
• Train and support site staff on study protocols and materials.
• Perform data checks in line with the Clinical Monitoring Plan.
• Resolve site issues promptly and elevate where needed.
• Follow up on quality issues as they arise.
• Prepare and finalise monitoring visit reports.
• Collect and upload essential documents to the eTMF on time.
• Support investigator selection and feasibility activities.
• Prepare sites for audits and regulatory inspections.

Conocimientos

Independent working

ICH-GCP knowledge

Communication skills

Drug development understanding

Educación

Bachelor's degree in science/health care

Descripción del empleo

About the company

Join a well-established Australian CRO with a strong APAC footprint, delivering trials across multiple therapeutic areas and all phases. You'll be part of a close-knit team that values your input and invests in your development.

About the opportunity

As a Senior CRA, you'll be central to delivering high-quality clinical trials, keeping studies safe, ethical and efficient while building lasting partnerships across sites and sponsors.

Duties

• FSP model
• Conduct site selection, initiation, interim monitoring and close-out visits
• Develop and drive patient recruitment plans with sites
• Train and support site staff on study protocols and materials
• Perform data checks in line with the Clinical Monitoring Plan
• Resolve site issues promptly and elevate where needed
• Follow up on quality issues as they arise
• Prepare and finalise monitoring visit reports
• Collect and upload essential documents to the eTMF on time
• Support investigator selection and feasibility activities
• Prepare sites for audits and regulatory inspections

Skills and Experience

• Bachelor's degree in a scientific discipline or health care is preferred
• Previous experience as a Senior CRA
• Minimum of 4 years of independent monitoring experience
• Excellent knowledge of ICH-GCP guidelines and local regulations
• Understanding of the drug development process
• Strong written, verbal, and computer skills
• Ability to work independently in remote environments

Culture

You'll join a collaborative, high-performing team where ownership is encouraged, ideas are heard and your work makes a real difference to clinical research across Asia-Pacific.