Contract Clinical Research Associate

Job not on LinkedIn

🔥 2 minutes ago

🇦🇺 Australia – Remote

⏱ Part Time

🟡 Mid-level

🧪 Clinical Research

Where this job comes from

Posted on Linical's careers page, not through a job board

First seen by Remote Rocketship 2 minutes ago

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Logo of Linical

Linical

501 - 1000 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Linical is a global Clinical Research Organization (CRO) that partners with biopharmaceutical companies to manage and support clinical trials across various therapeutic areas such as oncology, neurology, psychiatry, immunology, and endocrinology. With extensive expertise in drug development strategy, protocol development, regulatory consulting, and patient recruitment, Linical guides clients through every phase of their clinical development journey. They emphasize quality data capture, personalized service, and overcoming obstacles to ensure successful clinical trials, helping to bring new therapies to patients worldwide. Linical's global reach and award-winning services make them a reliable partner for conducting complex clinical studies.

📋 Description

• 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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