Clinical Trials Operations Coordinator

hace 2 semanas

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

Overview:

The Clinical Trials Operations Coordinator plays a pivotal role in providing both administrative and technical assistance to the Project Team. This position is essential for maintaining audit readiness by ensuring that documentation is reviewed in accordance with the organization's Standard Operating Procedures (SOP) and departmental guidelines. The coordinator will support site activation processes and contribute to the development of critical timelines for efficient site activations.

Key Responsibilities:

  • Coordinate and manage assigned trial activities as outlined in the task matrix, ensuring compliance with specific roles (Central or Local).
  • Conduct thorough reviews of department, internal, country, and investigator files, documenting findings in the appropriate systems.
  • Ensure that tasks are completed punctually, within budget, and to a high-quality standard, while proactively communicating any potential risks to project leads.
  • Provide system support for Activate & eTMF, ensuring that databases are consistently updated.
  • Handle administrative duties for assigned trials, including timely processing of documents and communications.
  • Analyze and reconcile study metrics and findings reports, assisting in the clarification and resolution of documentation-related issues.
  • Facilitate the coordination and distribution of Investigator Site Files (ISF) and other essential materials to sites.
  • Support the preparation of study-specific translation materials and quality control of translations as required.
  • Maintain up-to-date knowledge of SOPs, client directives, and current regulatory guidelines relevant to the services provided.
  • Where applicable, conduct on-site feasibility assessments.
  • Assist in scheduling client and internal meetings as necessary.
  • Review and track local regulatory documents.
  • Support the maintenance of study-specific documentation and systems, including project-specific training requirements and activity tracking.
  • Transmit documents to clients and centralized IRB/IEC as needed.
  • Maintain vendor trackers and assist the start-up team with regulatory submissions.
  • Collaborate with sites to obtain necessary documents for site selection.
  • Aid the project team in preparing regulatory compliance review packages.
  • Ensure alignment of site start-up activities with the activation critical path.
  • Document all communications and follow-ups related to site contacts and survey responses in real-time.
  • Review survey data for logical consistency and completeness.
  • Work collaboratively with team members to meet project deadlines and communicate site issues effectively.
  • Ensure a well-structured plan for site contact and follow-up, escalating any compliance concerns to management.
  • Act as a local expert on site capacity and experience, recommending additional sites as necessary.
  • Liaise with Global Investigator Services to address investigator queries promptly.
  • Contribute to the development and implementation of global strategic feasibility processes and best practices.
  • Train new personnel on relevant processes and systems.
  • Utilize local knowledge to identify and develop new site opportunities.

Qualifications:

A high school diploma or equivalent is required, with a preference for a Bachelor's degree. Relevant experience that equips the candidate with the necessary skills and abilities for the role is essential. In some cases, a combination of education, training, and directly related experience may be considered sufficient.

Skills and Competencies:

  • Ability to work effectively both independently and as part of a team.
  • Strong organizational skills and attention to detail, with the capacity to manage multiple tasks efficiently.
  • Proficient in analyzing project-specific data to ensure accuracy and efficiency.
  • Excellent customer service orientation.
  • Flexibility to adjust priorities in response to changing project timelines.
  • Knowledge of applicable country regulations, ICH Good Clinical Practices, and relevant SOPs.
  • Proficient in English and local languages as necessary, with strong communication skills.
  • Competent in MS Office applications and clinical trial database systems.
  • Self-motivated with a positive attitude and strong interpersonal skills.
  • Effective decision-making and judgment capabilities.
  • Strong negotiation skills and the ability to manage risks appropriately.

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