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Clinical Research Associate (Houston, TX) Ad id: 1407137450604494 |  Views: 144

Price: Contact Us
Date listed: 7 years ago
Clinical Research Associate Location: Home-Based: Candidate MUST live within 45 minutes or less from a major international airport.Job Type: Full-TimeDuration: PermanentCompensation: Open to discussionCOMPANYOur client is a France-based pharmaceutical company with a therapeutic focus on oncology, neurology and inflammatory diseases. POSITION SUMMARYWe are conducting the search for a Clinical Research Associate to monitor Phase 3 Human Critical Studies in the areas of Rheumatoid Arthritis and Multiple Sclerosis in various parts of the US. This is a full-time home based position and it will report to the Director of Clinical Operations in France. PRIMARY JOB FUNCTIONS:• Ensure that the Investigators are aware of their responsibilities and the need to comply with ICH-GCP, local regulatory requirements and protocol• Monitor US investigational site activities (pre-study, initiation, interim, and close-out visits) for compliance with ICH-GCP, applicable regulations and protocol, according to the company's SOPs• Ensure that study documentation is completed and properly maintained in accordance with all applicable regulations• Monitor Investigator compliance for reporting Adverse Events (AE) and Serious Adverse Events (SAE)• Monitor Investigational Medicinal Products (shipment, accountability, return and documentation)• Prepare and submit appropriate site visit reports within timelines• Resolve data queries with investigational sites• Provide regular study updates to the company management and update tracking tools• Performs additional duties and assignments as requestedOTHER REQUIREMENTS:• Willingness to travel 75% • Will cover various locations throughout the United States• Previous experience working with small pharma preferredEDUCATION/SKILL/EXPERIENCE REQUIREMENTS:• BS, BSN or RN• Qualified CRA with 2 to 5 years of field monitoring experience, preferably in Rheumatoid Arthritis and other inflammatory diseases• Located near (less than 30 minute car drive) a major airport• Experience with managing phase 2 and 3 studies• Strong knowledge of ICH-GCP, IRB/IEC procedures and FDA regulations • Solid knowledge base of medical terminology, clinical pharmacology and pathophysiology • Excellent written and verbal communication skills, fluent written and verbal English skills• Excellent organizational skills and ability to manage time and work independently• Computer proficient with the Microsoft Office suite of tools• Attention to detail and a methodical approach to work • Ability to organize and take initiative when indicated • Ability to handle and prioritize multiple assignments in a fast-paced work environment• Ability to identify issues proactively, identify resolutions and follow through APPLICATION This is an excellent opportunity for individuals seeking to work with a start-up/small company.Please submit your resume, current salary, salary expectations and include a cover letter indicating:• the number of sites managed at any one time in a study• the average number of patients per site monitored• the average number of site visits per month**please submit resumes directly to GCadavillo@irionline.com for consideration** Location: Houston, TX Compensation: open to discussionPrincipals only. Recruiters, please don't contact this job poster.Please do not contact job poster about other services, products or commercial interests.

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