Thermo Fisher Scientific dezvoltă și furnizează tehnologii, produse de laborator și servicii farmaceutice care sprijină cercetarea științifică și asistența medicală. Activitatea sa acoperă cercetarea în domeniul științelor vieții, rezolvarea problemelor analitice, creșterea productivității laboratoarelor, diagnosticarea, precum și dezvoltarea și producția de terapii. Compania își deservește clienții printr-o echipă globală și un portofoliu de mărci care include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon și PPD. Oportunitățile de carieră includ activitățile științifice, medicale, de producție, logistice și de servicii care susțin aceste oferte.
Clinical Trial Coordinator II – North Carolina Remote at Thermo Fisher Scientific
Support global pharmaceutical and biotechnology studies through site activation, regulatory documentation, feasibility activities, trial-file maintenance, metrics tracking, and investigator communications.
Descriere
- Manage assigned trial activities in line with the task matrix.
- Review department, internal, country, and investigator files and record findings.
- Deliver assigned work on schedule, within budget, and to required quality standards.
- Escalate project risks to project leads and the line manager.
- Process client eTMF documents, conduct eTMF reviews, distribute mass mailings, and share documents and reports with internal teams.
- Review and monitor local regulatory documentation.
- Analyze and reconcile study metrics and findings reports.
- Help clarify and resolve site documentation findings.
- Keep vendor tracking records up to date.
- Coordinate, assemble, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies.
- Support study-specific translation materials and perform translation quality checks.
- Provide technical and administrative project assistance with internal departments and colleagues.
- Stay current on SOPs, client instructions, and relevant regulatory requirements.
- Keep trial status information accurate and current in study databases.
- Build and maintain relationships with applicable client local affiliates.
- Promote the inclusion of Strategic Collaboration sites.
- Conduct on-site feasibility visits when applicable to Asia Pacific assignments.
- Train new staff on relevant processes and systems.
- Maintain study records, team rosters, training requirements, system access, and project activity plans.
- Support Activate, eTMF, and risk-based monitoring work.
- Send documents to clients and centralized IRB/IEC bodies.
- Participate in kick-off meetings and document discussions when needed.
- Arrange client and internal meetings and prepare minutes.
- Work with internal departments to align site start-up work with the site activation critical path.
- Assist with regulatory compliance review packages and submissions.
- Collect site-selection documentation directly from sites when required.
- Create site lists and maintain investigator and site staff contact information.
- Complete CTMS Site Interest Plans and record site communications and survey responses.
- Check survey responses for logical consistency, completeness, and relevance.
- Work with teammates to meet deadlines and resolve site issues and risks.
- Maintain effective site contact and follow-up plans and escalate non-compliance.
- Act as a local resource on site capacity and experience and support local site tiering.
- Interview physicians and site personnel by phone to gather protocol-level feedback.
- Partner with Global Investigator Services to resolve investigator questions and maintain account and contact records.
- Contribute to global strategic feasibility procedures and best practices.
Cerințe
- High school diploma or equivalent, along with relevant academic or vocational training.
- At least two years of comparable experience demonstrating the knowledge and skills required for the role.
- Equivalent combinations of education, training, and directly related experience may be accepted.
- Capacity to work effectively both independently and collaboratively.
- Strong organization skills and close attention to detail.
- Ability to handle multiple priorities efficiently and effectively.
- Ability to assess project data and systems for accuracy and efficiency.
- Strong commitment to customer service.
- Flexibility to adapt to changing project schedules.
- Working knowledge of applicable country regulations, ICH Good Clinical Practice, organizational or client SOPs, and WPDs.
- Excellent English communication and grammar skills, plus local-language proficiency where required.
- Competent presentation skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Ability to learn and use clinical trial databases and related software.
- Ability to complete the organization's clinical training program successfully.
- Clear written and verbal communication skills, including communication with medical professionals.
- Effective negotiation skills.
- Basic knowledge of medical or therapeutic areas and medical terminology.
- Foundational organizational and planning skills.
- Basic understanding of local healthcare systems.
- Working knowledge of GCP and applicable SOPs.
- Ability to operate effectively in a matrix organization.
- Strong relationship-building skills.
- Ability to think independently.
- Ability to manage risk and escalate issues appropriately.
- Availability for occasional driving to site locations and potential occasional travel.
Beneficii
- Fully remote work arrangement.
- Standard Monday-to-Friday schedule.