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Thermo Fisher Scientific
Thermo Fisher Scientific
H1B vīzas sponsorsLoģistikaRažošanaVeselības aprūpe
Thermo Fisher Scientific izstrādā un piegādā tehnoloģijas, laboratoriju produktus un farmācijas pakalpojumus, kas atbalsta zinātnisko pētniecību un veselības aprūpi. Uzņēmuma darbība aptver dzīvības zinātņu pētniecību, analītisko problēmu risināšanu, laboratoriju darba ražīgumu, diagnostiku, kā arī terapiju izstrādi un ražošanu. Uzņēmums apkalpo klientus ar globālas komandas un zīmolu portfeļa palīdzību, kurā ietilpst Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon un PPD. Uzņēmuma karjeras iespējas aptver zinātnes, veselības aprūpes, ražošanas, loģistikas un pakalpojumu darbības, kas nodrošina šos piedāvājumus.
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Vakances uzņēmumā

Remote Clinical Trial Coordinator I in Mexico

Supports pharmaceutical and biotech clinical trials remotely from Mexico. Coordinates site activation, feasibility, regulatory submissions, documentation, and clinical trial systems.

MXMeksikaAttālinātiPilna slodzeVidējais līmenisVecākais speciālistsNepieciešamā Valoda: angļuKlīnisko pētījumu koordinatorsVispārīgi

Apraksts

  • Provide administrative and technical support to project teams.
  • Review files against SOPs and departmental guidance to support audit readiness.
  • Assist with site activation administration and development of the site activation critical path.
  • Create and review feasibility site lists and contribute local insight to site tiering.
  • Coordinate and complete assigned trial activities in line with the task matrix.
  • Review departmental, internal, country, investigator, and eTMF files, and document findings.
  • Complete assigned work on time, within budget, and to quality standards; communicate risks to project leads.
  • Support Activate and eTMF systems and keep databases up to date.
  • Process documents for the client eTMF, conduct eTMF reviews, distribute communications, and provide documents and reports.
  • Analyze and reconcile study metrics and findings reports, and help resolve site documentation findings.
  • Coordinate and distribute Investigator Site File and pharmacy binder materials, along with non-clinical study supplies.
  • Assist with study-specific translations and translation quality checks.
  • Conduct on-site feasibility visits in Asia Pacific when applicable.
  • Coordinate client and internal meetings and track local regulatory documents.
  • Support risk-based monitoring activities and maintain study documentation and systems.
  • Send documents to clients and centralized IRB/IEC.
  • Keep vendor trackers current.
  • Assist with regulatory submissions and site start-up.
  • Obtain site-selection documents from sites and complete regulatory compliance review packages.
  • Record site contacts, follow-ups, and survey responses promptly; check survey data for completeness and consistency.
  • Work with teammates and clinical staff to meet deadlines and address site issues and risks.
  • Carry out site contact and follow-up plans, escalating concerns and non-compliance.
  • Apply local knowledge of site capacity and experience, recommend additional sites, and contribute to local site tiering.
  • Work with Global Investigator Services to resolve investigator questions and maintain account and contact details.
  • Contribute to global feasibility processes and practices.
  • Train new team members on processes and systems.
  • Use local knowledge to identify and develop new sites.
  • May serve as an onboarding buddy.

Prasības

  • High school diploma or equivalent, plus a relevant academic or vocational qualification.
  • A bachelor's degree is preferred.
  • Experience providing relevant knowledge and skills, comparable to 0–1 year.
  • A suitable combination of education, training, or directly related experience may meet the role requirements in some cases.
  • Ability to work independently or as part of a team, as needed.
  • Strong organization and attention to detail, with the ability to manage multiple tasks effectively.
  • Ability to analyze project-specific data and systems to ensure accuracy and efficiency.
  • Strong customer focus.
  • Flexibility to reprioritize work as project timelines change.
  • Ability to build and maintain working knowledge of applicable country regulations, ICH Good Clinical Practice, and organization and client SOPs and WPDs for clinical and non-clinical project implementation, execution, and closeout.
  • Good English grammar and language skills, plus proficiency in the local language as needed.
  • Computer proficiency, including MS Word, Excel, and PowerPoint, and ability to learn and master clinical trial database systems.
  • Ability to complete the organization's clinical training program successfully.
  • Self-motivated, positive, and personable.
  • Effective written and verbal communication skills.
  • Sound judgment and decision-making ability.
  • Ability to follow project work instructions accurately.
  • Good negotiation skills.
  • Independent thinking.
  • Ability to manage risk and escalate it appropriately.
  • Occasional driving to site locations and travel may be required.

Saistītās vakances

Worldwide Clinical Trials

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1001 – 5000 Darbinieki
H1B vīzas sponsorsKonsultācijasLoģistikaVeselības aprūpe
ARArgentīnaBRBrazīlijaMXMeksikaAttālinātiPilna slodzeJaunākais speciālistsVidējais līmenisNepieciešamā Valoda: angļuAsociētais speciālistsVispārīgi
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KonsultācijasMārketingsPersonāla atlase
ARArgentīnaBOBolīvijaBRBrazīlijaCLČīleCOKolumbijaCRKostarikaCUKubaDODominikānaECEkvadoraGTGvatemalaHNHondurasaHTHaitiMXMeksikaNINikaragvaPAPanamaPEPeruPRPuertorikoPYParagvajaSVSalvadoraUYUrugvajaVEVenecuēla
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