Contract Clinical Research Associate
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Job Description
Contract Clinical Research Associate supporting Australian clinical trials for Linical, a global clinical research organization. Conducting site monitoring, compliance, documentation, and study coordination remotely.
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 study 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 ensure 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
Requirements:
- Strong knowledge of clinical trial processes, ICH-GCP guidelines, and applicable regulatory requirements
- Excellent written and verbal communication skills
- Strong organisational, time management, and problem-solving abilities
- Ability to effectively manage multiple priorities and deadlines
- Proficiency in clinical trial systems and Microsoft Office applications
- Strong interpersonal skills and ability to work collaboratively within global teams
- Commitment to quality, accuracy, and patient safety
- Ability to travel up to 75% as required
- Valid driver's licence
- Bachelor's degree in Life Sciences, Nursing, or a related field, or an equivalent combination of education and relevant experience
- Successful completion of a recognised CRA training programme
- Minimum of 3 years' clinical research experience, including experience as a Clinical Trial Associate, Study Coordinator, Clinical Research Associate, or similar role
- Experience independently conducting site monitoring visits across all phases of a clinical trial
- Strong understanding of site management, protocol compliance, patient safety, and data quality requirements
Benefits:
- Remote work arrangement
- Part-time schedule (0.4 FTE)
- Flexible working
- Opportunity to work closely with investigative sites and cross-functional study teams
- Global team collaboration
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