Clinical Research Associate II

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $95k - $135k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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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, conduct site qualification visits, review site regulatory documents, and prepare site qualification reports and documentation • Participate in the 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 and prepare associated reports • Conduct site monitoring visits and follow-up to identify problems and ensure compliance with study plans, GCPs, and applicable regulations • Review 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 as requested • Ensure training is timely, current, and 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 according to project guidelines • Ensure timely transmission of clinical data to data management and review and clarify data queries • Conduct site close-out visits, including final investigational product reconciliation and disposition, file review, and document retrieval for the Trial Master File • Prepare site close-out reports and documentation • Attend team meetings as required • Participate in systems User Acceptance Testing as required • Perform other duties as assigned • Report to the Senior Manager of Site Management and Monitoring

🎯 Requirements

• 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 • Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs, and the scientific/clinical knowledge to understand the nature of drugs being studied • Excellent written and verbal communication skills • Time management, organizational, and problem-solving skills • Fluent in the local language (speaking and writing) and 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 • 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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