Clinical Trial Associate

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $70k - $73k / year

⏰ Full Time

🟡 Mid-level

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This company has sponsored H1B visas in the past.

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Clinilabs

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Clinilabs is a global, full-service Contract Research Organization (CRO) specializing in the development of central nervous system (CNS) drugs, devices, and technology. The company provides comprehensive services to pharmaceutical, biotechnology, and medtech organizations, supporting their projects from first-in-human to Phase 3 clinical trials. Clinilabs is dedicated to addressing the significant unmet needs in CNS drug development, focusing on neurological, mental health, and substance use disorders.

📋 Description

• Support the clinical study team with administrative duties • Collect and review essential regulatory documents, including 1572s, Informed Consents, Financial Disclosures and CVs • Communicate required document changes to Project Managers, LCRAs or site staff • Assist with Central IRB submissions • Track study status • Maintain the Clinical Trial Management System (CTMS) • Create, maintain and archive the Trial Master File (TMF) • Ship study supplies • Set up and organize meetings • Draft study meeting agendas and minutes • Liaise with Clinilabs’ clients as required per study • Assist with site payment reconciliation • Perform other study-related administrative duties • Assist with training new Clinical Trials Assistants • Participate in Clinical Operations departmental initiatives • Support Project Managers and drive study start-up processes, including feasibility, Informed Consent and TMF set-up

🎯 Requirements

• High School diploma or equivalent a must • Some college or technical experience required • At least 3-4 years of work experience in a clinical research role within a Pharmaceutical, Biotechnology Industry and/or CRO environment • In lieu of clinical research experience, at least 6 years in a health care setting • Knowledge of GCP guidelines, FDA guidelines, medical terminology and clinical trial processes • Strong organizational skills with attention to details • Excellent communication skills (written and verbal) • Strong computer skills (Word, Excel, Document management systems) • Ability to manage and prioritize multiple tasks and projects • Ability to adapt to a fast-past and changing environment • Excellent interpersonal skills, ability to work in teams and in close collaboration with others • Ability to work independently and assist with improving the Clinical Trial Associate function and tools used by the person in this role • Ability to support Project Managers and drive the study start-up process, including feasibility, Informed Consent and TMF set-up

🏖️ Benefits

• Fully remote work arrangement • Travel between company offices may be required from time to time • Professional development through assisting with training new Clinical Trials Assistants • Participation in Clinical Operations departmental initiatives

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