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
Support pharmaceutical and biotech studies with site activation, regulatory documentation, feasibility work, and study administration. This role is fully remote in North Carolina.
Descriere
- Coordinate and complete 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.
- Report project risks to project leads and the line manager.
- Process client eTMF submissions, review eTMF records, distribute mass mailings, and share documents and reports with internal teams.
- Review and track local regulatory documents.
- Analyze and reconcile study metrics and findings reports.
- Keep vendor trackers up to date.
- Compile and distribute Investigator Site File and Pharmacy binder materials, along with non-clinical study supplies.
- Support study-specific translations and translation quality checks.
- Provide technical and administrative project support with internal departments and colleagues.
- Stay current on SOPs, client directives, and regulatory guidance.
- Keep trial status information accurate and current in databases.
- Build relationships with client local affiliates where applicable.
- Train new staff on processes and systems.
- Maintain study records, team lists, training requirements, system access, and project activity trackers.
- Support Activate and eTMF systems, risk-based monitoring activities, document transmission, meetings, minutes, and scheduling.
- Coordinate across internal departments to keep site start-up aligned with the site activation critical path.
- Assist with regulatory compliance review packages and submissions.
- Request site-selection documents directly from sites when needed.
- Create site lists and maintain investigator and site staff contact details.
- Complete Site Interest Plans in CTMS and record site communications and survey responses.
- Check survey data for logical, complete, and relevant responses.
- Work with teammates and clinical staff to address site issues and risks.
- Maintain effective site contact and follow-up plans, escalating non-compliance.
- Collect local insight on site capacity and experience, and recommend additional sites.
- Interview physicians and site staff by phone to gather protocol-level input.
- Work with Global Investigator Services to resolve investigator questions and maintain account and contact details.
- Contribute to global strategic feasibility processes and best practices.
Cerințe
- High school diploma or equivalent, plus relevant formal academic or vocational qualification.
- At least two years of comparable experience providing the knowledge, skills, and abilities needed for the role.
- Equivalent qualifications may be considered through a combination of appropriate education, training, and directly related experience.
- Able to work both collaboratively and independently.
- Strong organization skills and attention to detail.
- Able to manage multiple tasks efficiently and effectively.
- Able to analyze project-specific data and systems for accuracy and efficiency.
- Strong customer focus.
- Flexible and adaptable as project timelines change.
- Working knowledge of applicable country regulations, ICH Good Clinical Practice, and organization or client SOPs and WPDs.
- Excellent English language and grammar skills, plus proficiency in the local language as needed.
- Good presentation skills.
- Proficiency in MS Office, including Word, Excel, and PowerPoint.
- Able to learn and master clinical trial database systems and relevant software.
- Able to complete the organization's clinical training program successfully.
- Effective spoken and written communication, including with medical personnel.
- Good negotiation skills.
- Basic knowledge of medical or therapeutic areas and medical terminology.
- Basic organization and planning skills.
- Basic knowledge of local health systems.
- Working knowledge of GCP and applicable SOPs.
- Able to work in a matrix environment.
- Able to build relationships.
- Able to think independently.
- Able to manage risk and escalate it appropriately.
Beneficii
- Fully remote work arrangement.
- Standard Monday to Friday schedule.