Senior Clinical Research Associate

Health and Aged Care Professionals; Sydney; Sur place; AUD 120 000 - 160 000; Plein temps

Résumé du poste

Health and Aged Care Professionals in Sydney is seeking a Senior CRA to lead clinical monitoring across sites in the Asia-Pacific region. You will ensure trial safety, ethics and efficiency while building partnerships with investigators and sponsors.

The role requires 4+ years of independent monitoring, a strong knowledge of ICH-GCP and the drug development process, and the ability to work remotely in a collaborative, high-performance team.

Qualifications

• Bachelor’s degree in a scientific discipline or health care.
• 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.

Responsabilités

• 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 escalate 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.

Connaissances

Independent monitoring

Communication skills

Written skills

Verbal skills

Computer skills

Formation

Bachelor’s degree in science or health

Description du poste

Health and Aged Care Professionals – Sydney NSW

Full time

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 *escalate* 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.