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Thermo Fisher Scientific
Thermo Fisher Scientific
H1B Visa SponsorHealthcareLogisticsManufacturing
Thermo Fisher Scientific develops and delivers technologies, laboratory products, and pharmaceutical services that support scientific research and healthcare. Its work spans life sciences research, analytical problem-solving, laboratory productivity, diagnostics, and the development and manufacturing of therapies. The company serves customers through a global team and a portfolio of brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. Its careers encompass the scientific, healthcare, manufacturing, logistics, and service operations behind these offerings.
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Clinical Trial Coordinator – Colombia (Remote)

Coordinate pharmaceutical and biotech clinical trials in Colombia, supporting site activation, regulatory records, feasibility, and investigator sites. Maintain trial documentation and eTMF systems while helping sites and study teams keep activities on track.

COColombiaRemoteFull-timeMiddleSeniorEnglish RequiredClinical Trial CoordinatorGeneral

Description

  • Coordinate assigned trial activities in line with the task matrix.
  • Review department, internal, country, and investigator files, recording findings.
  • Complete assigned work on schedule, within budget, and to quality standards.
  • Support Activate and eTMF systems and keep databases up to date.
  • Process and review trial documents, distribute communications, and prepare reports for internal teams.
  • Analyze and reconcile study metrics and findings reports.
  • Coordinate and distribute Investigator Site File and Pharmacy binder materials, along with non-clinical study supplies.
  • Support study-specific translation materials and check translation quality.
  • Stay current on SOPs, client directives, and regulatory guidelines.
  • Support meeting scheduling, local regulatory document tracking, RBM activities, documentation, access management, and activity plans.
  • Send documents to clients and centralized IRB/IEC.
  • Maintain vendor trackers and assist with regulatory submissions.
  • Work with sites to collect site-selection documents.
  • Assist with regulatory compliance review packages and site activation.
  • Complete Site Interest Plans in CTMS and, where applicable, collect related investigator and site documents.
  • Record site communications, follow-ups, and survey responses as they occur.
  • Check survey data for logical, complete, and accurate responses.
  • Work with teammates and clinical staff to meet deadlines and address site issues and risks.
  • Create and maintain site contact and follow-up plans, escalating concerns or non-compliance.
  • Provide local insight into site capacity, experience, tiering, and identification of potential new sites.
  • Work with Global Investigator Services to resolve investigator queries and maintain account and contact records.
  • Contribute to global feasibility processes and shared best practices.
  • Train new team members on processes and systems.

Requirements

  • High school diploma or equivalent, plus a relevant academic or vocational qualification.
  • Comparable experience of 0 to 1 year.
  • Bachelor's degree preferred.
  • Strong English language and grammar skills, with proficiency in the local language as needed.
  • Proficiency in MS Office, including Word, Excel, and PowerPoint.
  • Ability to learn and master clinical trial database systems.
  • Ability to complete the organization's clinical training program successfully.
  • Knowledge of applicable country regulations, ICH Good Clinical Practice, and organization and client SOPs and WPDs.
  • Ability to follow project work instructions accurately.
  • Ability to manage risk and escalate it appropriately.
  • Occasional driving to site locations and possible occasional travel.

Benefits

  • Fully remote work arrangement.
  • Standard Monday-to-Friday schedule.
  • Occasional travel may be required.
  • Training is provided for new personnel and through the clinical training program.

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