Full-Time Clinical Research Associate for inVentiv Health Clinical
Job Description
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inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.
As a Clinical Research Associate (II) you will successfully perform routine site visits to ensure that the rights and well being of human subjects are protected. You will verify that the reported trial data are accurate, complete, and verifiable from source documents. You will ensure that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines and other applicable regulatory requirements.
Main Responsibilities:
• Perform routine site visits, including pre-study, initiation, interim, and closeout visits
• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements
• Monitor on-going processes – informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance
• Perform detailed reviews of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures
• Report as per internal procedures any findings noted during the monitoring visits to the inVentiv project team, client, and site personnel
• Maintain eClinical or alternative project tracking system of subject and site information.
• Perform responsibilities with minimal support from management
Qualifications/Requirements:
• Previous Oncology clinical monitoring experience is essential
• Bachelor’s Degree in Life sciences, Pharmacy, Nursing or RN, or equivalent
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Position requires approximately 60% travel (may be up to 80% during peak times)
In return we will offer:
• Competitive remuneration package with excellent benefits including healthcare and pension
• Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
• Opportunity to work within a successful and rewarding environment
Do not hesitate to contact Mateusz Korman for further information: mateusz.korman@inventivhealth.com / +48 (0) 12 290 7832.
Let’s dialogue and we are looking forward to speaking with YOU!
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