Clinical Trial Coordinator FSP LATAM

hace 2 semanas

Bogotá, Bogotá D.E., Colombia myGwork A tiempo completo
Job Description

This role is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Job Summary

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.

Key Responsibilities
  • Coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
  • Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
  • Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
  • Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
  • Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
  • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assists with study-specific translation materials and translation QC upon request.
  • Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Where applicable, conducts on-site feasibility visits (Asia Pac only).
  • May support scheduling of client and/or internal meetings.
  • May review and track of local regulatory documents.
  • May provide system support (i.e., Activate & eTMF). May support RBM activities.
  • May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s).
  • Transmits documents to client and centralized IRB/IEC.
  • Maintains vendor trackers.
  • Supports start-up team in Regulatory submissions.
  • Works directly with sites to obtain documents related to site selection.
  • Assists the project team with the preparation of regulatory compliance review packages.
  • Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
  • May complete the 'Site Interest Plan' in CTMS and collection and delivery of associated documents from investigators and site personnel.
  • Documents in real time all communication, attempts and follow up associated with site contact and survey responses.
  • Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
  • Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
  • Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalate concerns/non-compliance to management.
  • May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harness this knowledge base when performing local tiering of sites.
  • Liaises with Global Investigator Services to resolve investigator queries in real time and maintain 'accounts and contact' information.
  • Contributes to the development and roll-out of global strategic feasibility processes and best practices.
  • Trains new personnel in processes and systems.
  • Utilizes local knowledge to contribute to the identification and development of new sites.

  • Clinical Trial Coordinator FSP LATAM

    hace 15 horas

    Bogotá, Bogotá D.E., Colombia myGwork A tiempo completo

    Clinical Trial Coordinator FSP LATAM Role SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team at Thermo Fisher Scientific, a leading company in the life sciences industry.Key Responsibilities:Provide administrative and technical support to the Project Team, ensuring timely completion of tasks and accurate...

  • Clinical Trial Coordinator FSP LATAM

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team in FSP LATAM. The successful candidate will provide administrative and technical support to the Project Team, ensuring the smooth execution of clinical trials.Key ResponsibilitiesCoordinate and oversee trial activities, ensuring timely completion and...

  • Clinical Trial Coordinator FSP LATAM

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team in FSP LATAM. The successful candidate will provide administrative and technical support to our project team, ensuring the smooth execution of clinical trials.Key ResponsibilitiesCoordinate and oversee trial activities, ensuring timely completion and...

  • Clinical Trial Coordinator FSP LATAM

    hace 1 semana

    Bogotá, Bogotá D.E., Colombia myGwork A tiempo completo

    Job SummaryAs a Clinical Trial Coordinator FSP LATAM, you will provide administrative and technical support to the Project Team, ensuring audit readiness by reviewing files according to the schedule detailed in the organization's SOP and department guidance document. You will also provide administrative support for site activation activities, aid in the...

  • Clinical Trial Coordinator FSP LATAM

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia myGwork A tiempo completo

    Job DescriptionThis role is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. We value diversity and promote a culture of inclusion.Job SummaryAs a Clinical Trial Coordinator FSP LATAM, you will provide administrative and technical support to the Project Team. Your...

  • Clinical Trial Coordinator FSP LATAM

    hace 2 meses

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team at Thermo Fisher Scientific. As a Clinical Trial Coordinator, you will play a critical role in supporting the project team by providing administrative and technical assistance.Key ResponsibilitiesCoordinate and oversee trial activities as detailed on...

  • Clinical Trial Coordinator FSP LATAM

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team in LATAM. The successful candidate will provide administrative and technical support to our project team, ensuring the smooth execution of clinical trials.Key ResponsibilitiesCoordinate and oversee trial activities, ensuring timely completion and...

  • Clinical Trial Coordinator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

    Clinical Trial Coordinator **Job Summary** We are seeking a highly motivated and organized Clinical Trial Coordinator to join our team at CDS Fortrea Inc. As a Clinical Trial Coordinator, you will be responsible for coordinating clinical trials, managing site performance, and ensuring compliance with study protocols. **Responsibilities** * Serve as the...

  • Clinical Trial Coordinator

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

    Job Title: Sr Clinical Trial CoordinatorFortrea is seeking a highly motivated and organized Sr Clinical Trial Coordinator to join our team. As a key member of our clinical operations team, you will be responsible for coordinating and managing clinical trials from start to finish.Responsibilities:Coordinate and manage site contacts, including creating contact...

  • Clinical Trial Coordinator

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

    Job Title: Sr Clinical Trial CoordinatorAt CDS Fortrea Inc., we are seeking a highly motivated and detail-oriented Sr Clinical Trial Coordinator to join our team. As a key member of our clinical operations team, you will be responsible for coordinating and managing clinical trials from start to finish.Responsibilities:Serve as the primary point of contact...

  • Clinical Trial Coordinator FSP LATAM

    hace 1 semana

    Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team. The successful candidate will provide administrative and technical support to our project team, ensuring the smooth execution of clinical trials.Key ResponsibilitiesCoordinate and oversee trial activities, ensuring timely completion and high-quality...

  • Clinical Trial Coordinator

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

    Job Title: Sr Clinical Trial CoordinatorCDS Fortrea Inc. is seeking a highly motivated and detail-oriented Sr Clinical Trial Coordinator to join our team. As a key member of our clinical operations team, you will be responsible for coordinating and managing clinical trials from start to finish.Responsibilities:Serve as the primary point of contact for...

  • Clinical Trial Coordinator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

    Job Title: Sr Clinical Trial CoordinatorCDS Fortrea Inc. is seeking a highly motivated and detail-oriented Sr Clinical Trial Coordinator to join our team. As a key member of our clinical operations team, you will be responsible for coordinating and managing clinical trials from start to finish.Responsibilities:Serve as the primary point of contact for...

  • Clinical Trial Coordinator

    hace 15 horas

    Bogotá, Bogotá D.E., Colombia ICON A tiempo completo

    Clinical Trial Administrator Role at ICONICON plc is a world-leading healthcare intelligence and clinical research organization, dedicated to fostering an inclusive environment that drives innovation and excellence. We are proud to offer a dynamic and diverse work environment where you can contribute to shaping the future of clinical development.We are...

  • Clinical Trial Coordinator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia ICON A tiempo completo

    Job Title: Clinical Trial AdministratorAt ICON, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Clinical Trial Administrator to join our dynamic team.Key Responsibilities:Coordinate and administer clinical trials, ensuring compliance with protocols and regulatory...

  • Clinical Trial Administrator

    hace 1 semana

    Bogotá, Bogotá D.E., Colombia Icon plc A tiempo completo

    Unlock Your Potential in Clinical ResearchAt ICON plc, we're committed to fostering a culture of innovation and excellence in clinical research. As a Clinical Trial Administrator, you'll play a pivotal role in shaping the future of clinical development.Key Responsibilities:Coordinate and administer clinical trials, ensuring compliance with protocols and...

  • Clinical Trial Administrator

    hace 6 días

    Bogotá, Bogotá D.E., Colombia myGwork A tiempo completo

    Clinical Trial AdministratorAt ICON plc, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a skilled Clinical Trial Administrator to join our diverse and dynamic team.This role will play a pivotal part in assisting with the design and analysis of clinical trials, interpreting complex medical data, and...

  • Clinical Trial Administrator

    hace 1 semana

    Bogotá, Bogotá D.E., Colombia ENGINEERINGUK A tiempo completo

    Job Title: Clinical Trial AdministratorAt ICON, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Clinical Trial Administrator to join our dynamic team.Key Responsibilities:Coordinate and administer clinical trials, ensuring compliance with protocols and regulatory...

  • Clinical Trial Administrator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia myGwork A tiempo completo

    Job Title: Clinical Trial AdministratorICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.About the RoleWe are currently seeking a Clinical Trial...

  • Clinical Trial Coordinator

    hace 1 semana

    Bogotá, Bogotá D.E., Colombia CDS Fortrea Inc. A tiempo completo

    As a leading global contract research organization (CRO), CDS Fortrea Inc. provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, CDS Fortrea Inc. is...