Thermo Fisher Scientific ilmiy tadqiqotlar va sog‘liqni saqlashni qo‘llab-quvvatlaydigan texnologiyalar, laboratoriya mahsulotlari hamda farmatsevtika xizmatlarini ishlab chiqadi va taqdim etadi. Kompaniya faoliyati hayot fanlari bo‘yicha tadqiqotlar, tahliliy muammolarni hal qilish, laboratoriya samaradorligi, diagnostika, shuningdek, davolash usullarini ishlab chiqish va ishlab chiqarishni qamrab oladi. Kompaniya Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon va PPD kabi brendlar portfeli hamda global jamoasi orqali mijozlarga xizmat ko‘rsatadi. Uning karyera yo‘nalishlari ushbu takliflar ortidagi ilmiy, sog‘liqni saqlash, ishlab chiqarish, logistika va servis operatsiyalarini qamrab oladi.
Remote Clinical Trial Coordinator II – North Carolina
Coordinate pharmaceutical and biotechnology clinical trials remotely from North Carolina, supporting site activation, regulatory records, eTMF reviews, feasibility, and study operations.
Tavsif
- Coordinate assigned clinical trial activities in line with the task matrix.
- Review department, internal, country, and investigator files, and document findings.
- Deliver assigned work on time, within budget, and to quality standards; flag risks to project leads and the line manager.
- Process client eTMF documents, conduct eTMF reviews, distribute mailings and communications, and report to internal teams.
- Review and track local regulatory documents.
- Analyze and reconcile study metrics and findings, and help resolve site documentation issues.
- Maintain vendor trackers and study status records in databases.
- Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials, along with non-clinical study supplies.
- Support study-specific translation materials and check translation quality.
- Provide technical and administrative project support to internal departments and team members.
- Stay current on SOPs, client directives, and regulatory guidance.
- Maintain study records, team lists, training requirements, system access, activity plans, and eTMF schedules.
- Support Activate and eTMF systems and, as needed, risk-based monitoring activities.
- Send documents to clients and centralized IRBs or IECs.
- Attend study kickoff meetings, take notes, and help arrange meetings and prepare minutes.
- Coordinate across internal departments to keep site start-up aligned with the site activation critical path.
- Help prepare regulatory compliance review packages and submissions.
- Gather site-selection documents and build site lists through internal and external research.
- Keep investigator and site staff contact information current in company systems.
- Complete Site Interest Plans in CTMS and record site communications and survey responses.
- Check survey data for logical, complete, and relevant answers.
- Work with teammates and clinical staff on site issues, risks, deadlines, and follow-up plans.
- Advise on local site capacity and experience, support site tiering, and recommend additional sites.
- Interview physicians and site personnel to gather protocol-level input for trial optimization.
- Work with Global Investigator Services to resolve investigator queries and maintain account and contact details.
- Contribute to global strategic feasibility processes and shared best practices.
- Train new team members and support departmental process improvements.
Talablar
- High school diploma or equivalent, plus a relevant academic or vocational qualification.
- At least two years of comparable experience demonstrating the knowledge and skills needed for the role.
- Equivalent preparation through a combination of relevant education, training, or directly related experience may be considered.
- Ability to work independently and as part of a team.
- Strong organization and attention to detail, with the ability to manage multiple tasks efficiently.
- Ability to assess project-specific data and systems for accuracy and efficiency.
- Strong customer focus.
- Flexibility to adapt to changing project timelines.
- Working knowledge of applicable country regulations, ICH Good Clinical Practice, and organization or client SOPs and WPDs.
- Excellent English and grammar skills, with proficiency in the local language where needed.
- Good presentation skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint, and ability to learn clinical trial database systems.
- Ability to complete the organization's clinical training program successfully.
- Effective spoken and written communication, including communication with medical personnel.
- Strong interpersonal, negotiation, relationship-building, and risk-management skills.
- Basic knowledge of medical or therapeutic areas and medical terminology.
- Basic knowledge of organization, planning, and local health systems.
- Ability to work in a matrix environment.
- Ability to develop and maintain knowledge of GCP and applicable SOPs.
- Occasional driving to sites and potential occasional travel.
- Bachelor's degree preferred.
Imtiyozlar
- Fully remote work arrangement.
- Full-time employment.
- Standard Monday-to-Friday schedule.