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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

Clinical Trial Coordinator – Colombia (Remote)

Support pharmaceutical and biotechnology clinical trials remotely from Colombia. Coordinate site activation, regulatory documentation, feasibility activities, file reviews, and clinical trial systems.

COKolumbijaAttālinātiPilna slodzeVidējais līmenisVecākais speciālistsNepieciešamā Valoda: angļuKlīnisko pētījumu koordinatorsVispārīgi

Apraksts

  • Provide administrative and technical support to the Project Team
  • Support audit readiness through scheduled file reviews aligned with SOPs and department guidance
  • Provide administrative assistance for site activation activities
  • Help establish critical paths for site activation
  • Develop and review feasibility site lists and provide local input on site tiering
  • Coordinate and complete assigned trial activities according to the task matrix
  • Conduct department, internal, country, and investigator file reviews and document findings
  • Complete assigned work on schedule, within budget, and to quality standards while communicating risks to project leads
  • Support Activate and eTMF systems and maintain accurate databases
  • Process client eTMF documents, conduct eTMF reviews, distribute communications, and prepare reports
  • Analyze and reconcile study metrics and findings reports
  • Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
  • Support translation materials and perform translation quality control
  • Conduct on-site feasibility visits where applicable in Asia Pacific
  • Schedule client and internal meetings as needed
  • Review and track local regulatory documents as required
  • Support RBM activities and study-specific documentation and systems
  • Transmit documents to the client and centralized IRB/IEC
  • Maintain vendor tracking records
  • Support regulatory submissions and site start-up activities
  • Work with sites to obtain site-selection documents
  • Prepare regulatory compliance review packages
  • Coordinate with internal departments to align site start-up activities
  • Complete Site Interest Plans in CTMS and collect related investigator and site documents as needed
  • Record site communications, follow-ups, and survey responses in real time
  • Review survey data for logical, complete, and relevant responses
  • Collaborate with teammates and clinical personnel on deadlines, site issues, and risks
  • Maintain site contact and follow-up plans and escalate non-compliance
  • Provide local insight into site capacity and experience and recommend additional sites
  • Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information
  • Contribute to global feasibility processes and best practices
  • Train new personnel on processes and systems
  • Use local knowledge to identify and develop new sites

Prasības

  • High school or secondary school diploma, or equivalent, plus relevant formal academic or vocational training
  • Bachelor’s degree preferred
  • Previous experience comparable to 0–1 year
  • An equivalent combination of appropriate 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 accurately analyze project-specific data and systems
  • Strong customer focus
  • Flexibility to reprioritize workload
  • Working knowledge of applicable country regulations, ICH Good Clinical Practice, organizational or client SOPs, and WPDs
  • Good English language and grammar skills
  • Proficiency in the local language as required
  • Proficiency with Microsoft Office, including Word, Excel, and PowerPoint
  • Ability to learn and master clinical trial database systems
  • Ability to successfully complete the organization’s clinical training program
  • Effective verbal and written communication skills
  • Sound judgment and decision-making ability
  • Ability to follow project work instructions accurately
  • Good negotiation skills
  • Ability to manage risk and escalate risks appropriately

Priekšrocības

  • Fully remote work arrangement
  • Full-time position
  • Standard Monday-to-Friday schedule
  • Occasional travel may be required
  • Training and onboarding support
  • Opportunity to work with global pharmaceutical and biotechnology companies
  • Professional development through a clinical training program

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