Thermo Fisher Scientific ऐसी प्रौद्योगिकियाँ, प्रयोगशाला उत्पाद और फार्मास्युटिकल सेवाएँ विकसित तथा उपलब्ध कराती है, जो वैज्ञानिक अनुसंधान और स्वास्थ्य सेवा को समर्थन देती हैं। इसका कार्य जीवन विज्ञान अनुसंधान, विश्लेषणात्मक समस्याओं के समाधान, प्रयोगशाला उत्पादकता, निदान तथा उपचारों के विकास और निर्माण तक फैला हुआ है। कंपनी Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon और PPD सहित विभिन्न ब्रांडों के पोर्टफोलियो तथा एक वैश्विक टीम के माध्यम से ग्राहकों की सेवा करती है। इसके करियर अवसर इन उत्पादों और सेवाओं से जुड़ी वैज्ञानिक, स्वास्थ्य सेवा, विनिर्माण, लॉजिस्टिक्स और सेवा संचालन को शामिल करते हैं।
FSP Clinical Trial Coordinator at Thermo Fisher Scientific (Remote, North Carolina)
Support pharmaceutical and biotechnology clinical trials as a Clinical Trial Coordinator. Manage site activation, regulatory documentation, feasibility activities, trial systems, and investigator-site communication.
विवरण
- Coordinate and complete assigned trial activities in line with the task matrix
- Review department, internal, country, and investigator files and document findings
- Deliver assigned work on schedule, within budget, and to required quality standards
- Support Activate and eTMF systems while keeping study databases up to date
- Process client eTMF documents, conduct eTMF reviews, distribute communications, and prepare reports
- Analyze and reconcile study metrics and findings reports
- Coordinate and distribute Investigator Site File, pharmacy binder, and non-clinical study supply materials
- Support study-specific translation materials and perform translation quality checks
- Stay current with SOPs, client directives, and applicable regulatory guidance
- Assist with scheduling client and internal meetings
- Review and monitor local regulatory documentation
- Support risk-based monitoring activities and study documentation systems
- Maintain study team lists, training requirements, system access, and project activity plans
- Transmit documents to clients and centralized IRB/IEC bodies
- Keep vendor trackers accurate and current
- Support regulatory submissions and compliance review packages
- Work with sites to collect site-selection documentation
- Coordinate internal teams to align site start-up work with the activation critical path
- Complete CTMS Site Interest Plans and gather related investigator and site documents
- Record communications, follow-up actions, and survey responses in real time
- Check survey data for logical, complete, and relevant responses
- Work with teammates and clinical staff to address site issues and risks
- Implement site-contact and follow-up plans and escalate concerns or non-compliance
- Apply local knowledge of site capacity and experience to recommend additional sites
- Partner with Global Investigator Services to resolve investigator questions and maintain account and contact records
- Contribute to global feasibility strategy and related best practices
- Train new staff on processes and systems
- Use local market knowledge to identify and develop additional sites
आवश्यकताएँ
- High school diploma or equivalent, plus relevant formal academic or vocational training
- Bachelor's degree preferred
- Comparable prior experience of 0 to 1 year
- An equivalent combination of relevant education, training, and directly related experience may be considered
- Ability to work effectively both independently and as part of a team
- Strong organization and attention to detail
- Ability to manage multiple tasks efficiently and effectively
- Ability to evaluate project-specific data and systems for accuracy and efficiency
- Strong customer-oriented approach
- Ability to reprioritize work as needs change
- Working knowledge of applicable country regulations, ICH Good Clinical Practice, and organizational or client SOPs and WPDs
- Strong English language and grammar skills, with local-language proficiency where required
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Ability to learn and master clinical trial database systems
- Ability to complete the organization's clinical training program successfully
- Effective written and verbal communication skills
- Sound judgment and decision-making ability
- Ability to follow project work instructions accurately
- Good negotiation skills
- Ability to manage risks and escalate them appropriately
लाभ
- Fully remote work arrangement
- Standard Monday through Friday schedule