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. We value diversity and promote a culture of inclusion.

Job Summary

As a Clinical Trial Coordinator FSP LATAM, you will provide administrative and technical support to the Project Team. Your primary responsibility will be to ensure audit readiness by reviewing files according to the schedule detailed in the organization's SOP and department guidance document.

Key Responsibilities
  • Coordinate, oversee, and complete functions on assigned trial activities as detailed on the task matrix.
  • Perform department, internal, country, and investigator file reviews as assigned, and document findings in appropriate systems.
  • Ensure allocated tasks are performed on time, within budget, and to a high-quality standard.
  • Proactively communicate any risks to project leads.
  • Provide system support (i.e., Activate & eTMF) and ensure system databases are always current.
  • Perform administrative tasks on assigned trials, including 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.
  • Analyze and reconcile study metrics and findings reports.
  • Assist with clarification and resolution of findings related to site documentation.
  • Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assist with study-specific translation materials and translation QC upon request.
  • Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Where applicable, conduct on-site feasibility visits (Asia Pac only).
  • May support scheduling of client and/or internal meetings.
  • May review and track 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 systems.
  • Transmit documents to client and centralized IRB/IEC.
  • Maintain vendor trackers.
  • Support start-up team in Regulatory submissions.
  • Work directly with sites to obtain documents related to site selection.
  • Assist the project team with the preparation of regulatory compliance review packages.
  • Provide support as needed to coordinate with internal departments, ensuring site start-up 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.
  • Document in real-time all communication, attempts, and follow-up associated with site contact and survey responses.
  • Support the review of survey data to ensure responses are logical, complete, and reflective of the question asked.
  • Work in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
  • Ensure 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.
  • Liaise with Global Investigator Services to resolve investigator queries in real-time and maintain 'accounts and contact' information.
  • Contribute to the development and roll-out of global strategic feasibility processes and best practices.
  • Train new personnel in processes and systems.
  • Utilize local knowledge to contribute to the identification and development of new sites.
Requirements
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor's degree preferred.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Skills and Abilities
  • Ability to work in a team or independently as required.
  • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
  • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
  • Strong customer focus.
  • Flexibility to reprioritize workload to meet changing project timelines.
  • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution, and closeout.
  • Good English language and grammar skills and proficient local language skills as needed.
  • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
  • Ability to successfully complete the organization's clinical training program.
  • Self-motivated, positive attitude, and good interpersonal skills.
  • Effective oral and written communication skills.
  • Good interpersonal skills.
  • Essential judgment and decision-making skills.
  • Capable of accurately following project work instructions.
  • Good negotiation skills.
  • Independent thinker.
  • Ability to manage risk and perform risk escalation appropriately.

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