Thermo Fisher Scientific ғылыми зерттеулер мен денсаулық сақтау саласын қолдайтын технологияларды, зертханалық өнімдерді және фармацевтикалық қызметтерді әзірлеп, ұсынады. Компанияның қызметі өмір туралы ғылымдар саласындағы зерттеулерді, аналитикалық мәселелерді шешуді, зертхана өнімділігін арттыруды, диагностика жүргізуді, сондай-ақ емдеу әдістерін әзірлеу мен өндіруді қамтиды. Компания Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon және PPD сияқты брендтер портфелі мен жаһандық командасы арқылы клиенттерге қызмет көрсетеді. Оның мансаптық бағыттары осы ұсыныстардың негізіндегі ғылыми, денсаулық сақтау, өндірістік, логистикалық және сервистік операцияларды қамтиды.
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.
Сипаттама
- 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
Талаптар
- 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
Артықшылықтар
- Fully remote work arrangement
- Standard Monday through Friday schedule