Remote Contract Clinical Research Associate (0.4 FTE)

Linical; Australia; Remote; AUD 70,000 - 110,000; Part time

Job summary

Linical is seeking an experienced Contract Clinical Research Associate (CRA) to support the successful delivery of clinical trials across Australia. This is a remote, part-time opportunity (0.4 FTE) offering flexibility while working closely with investigative sites and cross-functional study teams.

You will conduct site qualification, initiation, monitoring, and close-out visits, ensure GCP compliance, train site personnel, manage regulatory submissions, and maintain TMF documentation.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or related field.
• Minimum of 3 years' clinical research experience.
• Experience as CRA/Study Coordinator or similar role.
• Oncology experience preferred.
• Willingness to travel up to 75%.
• Ability to work remotely across Australia.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits.
• Assess and identify suitable investigative sites and support site selection activities.
• Train site personnel on study protocols, regulatory requirements, and procedures.
• Ensure sites remain compliant with GCP, local regulations, sponsor requirements, and study protocols.
• Perform source data verification and review clinical documentation for accuracy, completeness, and consistency.
• Monitor investigational product accountability, storage, dispensing, and reconciliation.
• Support submissions to Ethics Committees and Regulatory Authorities as required.
• Manage site communications, action items, and issue resolution throughout the study lifecycle.
• Review and maintain essential study documentation within the Trial Master File (TMF).
• Facilitate data query resolution and timely reporting of study activities.
• Build and maintain relationships with investigators, study coordinators, and internal stakeholders.
• Participate in study team meetings and contribute to project success.

Skills

Clinical trial processes

ICH-GCP guidelines

Regulatory requirements

Communication skills

Time management

Team collaboration

Microsoft Office

Education

Bachelor's degree in Life Sciences or Nursing

CRA training programme

Tools

Clinical trial systems

Microsoft Office

Job description

Linical is seeking an experienced Contract Clinical Research Associate (CRA) to support the successful delivery of clinical trials across Australia. This is a remote, part-time opportunity (0.4 FTE) offering flexibility while working closely with investigative sites and cross-functional study teams.

You will conduct site qualification, initiation, monitoring, and close-out visits, ensure GCP compliance, train site personnel, manage regulatory submissions, and maintain TMF documentation.