Clinical Trial Associate

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $50k - $70k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 0%

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Linical

WebsiteLinkedInAll Job Openings

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

• Provide administrative support to the project team • Assist the Project Manager with communications to the project team and sites • Assist with site pre-identification and site feasibility • Collect initial essential documents from sites • Support study implementation activities, including regulatory and essential document preparation and IRB/IEC submissions • Create study-specific documents and materials • Maintain study organizational charts and project-specific trackers • Perform Principal Investigator background checks • Create Investigator Site Files and customize study templates • Upload and assign training documents in the Learning Management System and maintain the Project Team Training Matrix • Procure and ship study materials and supplies to sites and CRAs • Assist with Annual/Continuing Review IRB submissions in North America • Assist with meeting organization and prepare meeting minutes and action items • Request translations as required • File, review, classify, name, and maintain documents in the electronic Trial Master File according to the eTMF plan • Assist with periodic TMF quality-control reconciliation and project close-out • Create and structure project email accounts and assist with email filing • Maintain expert knowledge of Veeva Vault for eTMF and provide system user support • Perform other duties as assigned

🎯 Requirements

• Associate degree or equivalent experience • Minimum of two years of clinical research experience • Good written and verbal communication skills, including good command of English • Excellent interpersonal and communication skills • Awareness of ICH, GCP, FDA, MHRA, EMA regulations and local guidelines • Ability to work successfully in a matrixed team environment • Dedication to quality and attention to detail • Ability to prioritize and manage multiple tasks • Working knowledge of computer systems, applications, and operating systems • Ability to tolerate prolonged periods of sitting at a desk and working on a computer

🏖️ Benefits

• PTO • Comprehensive benefits