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।

Clinical Research Associate – France Remote

Monitor clinical trial sites in Germany for CTI, serving as their primary contact and supporting study visits, documentation, investigational products, and remote monitoring.

विवरण

  • Act as CTI’s primary contact for assigned clinical study sites.
  • Conduct pre-study, site initiation, interim monitoring, and close-out visits.
  • Deliver site visit documentation to quality standards and within Monitoring Plan timelines.
  • Support or oversee study start-up, feasibility reviews, pre-study activities, and site selection.
  • Gather, review, and track essential and regulatory documentation.
  • Complete required general and study-specific training.
  • Attend investigator, client, and project team meetings, and present when required.
  • Develop and carry out strategies to support subject enrollment.
  • Oversee appropriate storage, dispensing, and accountability of investigational products and trial materials.
  • Keep the Clinical Project Manager informed of site status.
  • Perform remote monitoring according to each study’s Monitoring Plan.
  • Use systems and reports to track subject status, CRF retrieval, source document review, regulatory records, and investigational products.
  • Contribute to project-specific work as part of the Project Team.

आवश्यकताएँ

  • 3–5 years of clinical research experience as a CRA or in a related role.
  • Independent clinical trial monitoring experience in Germany.
  • Background in life sciences.
  • Strong knowledge of ICH-GCP and applicable regulatory requirements.
  • Fluent spoken and written English, at least B2 level.
  • Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits.
  • Ability to manage sites and perform remote monitoring.
  • Ability to manage investigational products and trial-related materials.
  • Ability to collect, review, and track essential and regulatory documentation.

लाभ

  • Structured mentoring program.
  • Leadership development courses.
  • Dedicated training department.
  • Continued education support.
  • Hybrid work opportunities.
  • Opportunities to participate in CTI Cares community and charitable activities.
  • Work that contributes to treatments for patients with chronic and critical illnesses.

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