Clinical Research Associate II

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $95k - $120k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

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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

• Participate in identifying potential investigative sites and conduct site qualification visits • Collect and review site regulatory documents and prepare site qualification reports • Participate in final selection of investigative sites • Conduct site initiation visits and train site personnel on client and regulatory requirements • Participate in or conduct site and investigator meetings • Conduct site monitoring visits and follow up on significant problems and issues • Ensure clinical studies comply with study plans, GCPs, and applicable regulations • Review on-site files, records, Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance • Identify deficiencies and discrepancies and initiate corrective action • Assist with submissions to Independent Ethics Committees and Competent/Regulatory Authorities • Arrange site payments and facilitate site budgets and contracts • Ensure training is timely, current, and appropriately documented • Ensure protocol deviations are documented and action items are completed • Manage monitoring visit schedules and follow up on issues between visits • Maintain regular communication with site staff and the clinical study team • Monitor patient enrollment, enrolled patient status, investigational product supply, and site requests or issues • Ensure essential documents are filed in the Trial Master File • Ensure timely transmission of clinical data to data management • Review data queries and clarify or obtain data changes as appropriate • Conduct site close-out visits, including final investigational product reconciliation and disposition • Review file completeness and accuracy and retrieve documents for the Trial Master File • Prepare site close-out visit reports • Attend team meetings as required • Participate in systems User Acceptance Testing as required • Perform other duties as assigned

🎯 Requirements

• Proven experience in clinical research monitoring and site management • Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations, and GCPs • Scientific/clinical knowledge sufficient to understand the nature of drugs being studied • Excellent written and verbal communication, time management, organizational, and problem-solving skills • Fluent in the local language, speaking and writing • Good comprehension of English where English is not the local language • Excellent people skills and ability to work successfully in a matrixed team environment • Dedication to quality in all work tasks and deliverables • Ability to prioritize and manage multiple tasks, including during travel and monitoring visits • Working knowledge of computer systems, applications, and operating systems • Ability to travel up to 75% • Valid driver's license, as required • Life Science degree, nursing background, and/or combination of education or equivalent experience, combined with successful completion of a recognized CRA training program • Demonstrable monitoring and site management experience • Ability to tolerate prolonged periods of sitting at a desk and working on a computer • Ability to tolerate travel by car, air, or train as needed to support the job

🏖️ Benefits

• PTO • Comprehensive benefits

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