CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services एक कॉन्ट्रैक्ट रिसर्च ऑर्गनाइज़ेशन है, जो क्लिनिकल विकास की पूरी प्रक्रिया में जैव-प्रौद्योगिकी और फार्मास्यूटिकल प्रायोजकों को सेवाएँ प्रदान करता है। इसका कार्य फेज़ I–IV अध्ययनों में क्लिनिकल ट्रायल संचालन, नियामकीय रणनीति, प्रयोगशाला और बायोएनालिटिकल सेवाओं, वास्तविक-विश्व साक्ष्य तथा अनुसंधान केंद्र प्रबंधन तक फैला हुआ है। CTI को दुर्लभ रोगों, कोशिका और जीन थेरेपी, ऑन्कोलॉजी, न्यूरोलॉजी तथा प्रत्यारोपण जैसे क्षेत्रों में अनुभव है। यह अध्ययन डिज़ाइन, साइट प्रबंधन, रोगी भर्ती, निगरानी, सुरक्षा और फार्माकोविजिलेंस, बायोमेट्रिक्स तथा गुणवत्ता आश्वासन में सहायता करता है। कंपनी एकीकृत ट्रायल सेवाओं को रोगी-केंद्रित अनुसंधान और वैश्विक नियामकीय मार्गदर्शन के साथ जोड़ती है।

Senior Clinical Research Associate II – UK Remote

Senior Clinical Research Associate II overseeing UK clinical trial sites for CTI Clinical Trial and Consulting Services. The role includes site visits, remote monitoring, enrollment support, and regulatory compliance.

विवरण

  • Act as CTI’s primary contact for assigned clinical trial sites
  • Carry out pre-study, site initiation, interim monitoring, and close-out visits
  • Deliver all site visit documentation in line with the Monitoring Plan and required deadlines
  • Support or lead study start-up, feasibility, pre-study, and site selection activities
  • Gather, review, and maintain essential and regulatory documentation
  • Complete required training and attend investigator, client, and project team meetings
  • Develop and execute subject enrollment plans for assigned sites
  • Oversee the storage, dispensing, and accountability of investigational products and trial materials
  • Manage site activities and report site status to the Clinical Project Manager
  • Perform remote monitoring in accordance with the study-specific Monitoring Plan
  • Use systems and reports to monitor subject status, CRF retrieval, source document review, regulatory records, and investigational products
  • Contribute to project-specific work as a member of the Project Team

आवश्यकताएँ

  • Three to five years of clinical research experience as a CRA or in a related profession
  • Background in life sciences
  • Strong knowledge of ICH-GCP and applicable regulatory requirements
  • Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits
  • Ability to complete site visit deliverables within required deadlines
  • Knowledge of applicable regulations, standard operating procedures, and ICH-GCP
  • Ability to support or oversee study start-up, feasibility, pre-study, and site selection activities
  • Ability to collect, review, and track essential and regulatory documents
  • Ability to complete required general and study-specific training
  • Ability to participate in investigator, client, and project team meetings, including presentations
  • Ability to develop and implement subject enrollment strategies
  • Ability to manage investigational products and trial-related materials
  • Ability to conduct site management and remote monitoring activities
  • Ability to use systems and reports to track subject status, CRF retrieval, source document review, regulatory documents, and investigational products

लाभ

  • Structured mentoring program
  • Leadership development courses
  • Dedicated training department
  • Support for continuing education
  • Hybrid work opportunities
  • CTI Cares community and global giving opportunities
  • Work contributing to the development of life-changing treatments

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