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Clinical Research Project Coordinator LATAM

hace 2 meses

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

Overview:

The Clinical Trial Coordinator plays a pivotal role in providing both administrative and technical assistance to the Project Team. This position is crucial 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 supports site activation efforts and contributes to the development of timelines for rapid site activations within assigned projects. This role also represents the Clinical Research Group (CRG) personnel effectively.

Key Responsibilities:

  • Depending on the specific role (Central or Local), coordinates, oversees, and executes tasks related to assigned trial activities as outlined in the task matrix.
  • Conducts reviews of departmental, internal, country, and investigator files as assigned, documenting findings in the appropriate systems.
  • Ensures that all assigned tasks are completed on schedule, within budget, and to a high-quality standard, while proactively communicating any potential risks to project leads.
  • Provides system support (e.g., Activate & eTMF) and ensures that system databases are consistently updated.
  • Manages administrative duties for assigned trials, including timely processing of documents sent to the Client (e)TMF, conducting (e)TMF reviews, and distributing communications as necessary.
  • Analyzes and reconciles study metrics and findings reports, assisting in the clarification and resolution of any discrepancies related to site documentation.
  • Aids in the coordination, compilation, and distribution of Investigator Site Files (ISF) and Pharmacy binder materials, as well as non-clinical study supplies to sites.
  • Supports the preparation of study-specific translation materials and conducts translation quality control upon request.
  • Maintains a thorough understanding of SOPs, client SOPs/directives, and current regulatory guidelines relevant to the services provided.
  • Where applicable, conducts on-site feasibility assessments.
  • May assist in scheduling client and/or internal meetings.
  • May review and track local regulatory documents.
  • Provides system support (e.g., Activate & eTMF) and may assist with Risk-Based Monitoring (RBM) activities.
  • Aids in maintaining study-specific documentation and systems, including tracking project-specific training requirements and managing system access.
  • Facilitates the transmission of documents to clients and centralized Institutional Review Boards (IRB)/Ethics Committees (IEC).
  • Maintains vendor trackers and supports the start-up team in regulatory submissions.
  • Collaborates directly with sites to obtain necessary documents related to site selection.
  • Assists the project team in preparing regulatory compliance review packages.
  • Provides support to coordinate with internal departments, ensuring that site start-up activities align with the site activation critical path.
  • May complete the 'Site Interest Plan' in Clinical Trial Management Systems (CTMS) and manage the collection and delivery of associated documents from investigators and site personnel.
  • Documents all communications, attempts, and follow-ups related to site contact and survey responses in real-time.
  • Assists in reviewing survey data to ensure responses are logical, complete, and reflective of the questions posed.
  • Collaborates with team members to meet targeted deadlines for assigned projects, communicating site issues and risks to the appropriate clinical personnel.
  • Ensures an efficient and effective plan is in place for site contact and follow-up, escalating any concerns or non-compliance to management.
  • May serve as a local expert regarding site capacity and experience, working with key local personnel to gather insights and recommend additional sites.
  • Liaises with Global Investigator Services to resolve investigator queries promptly and maintain accurate accounts and contact information.
  • Contributes to the development and implementation of global strategic feasibility processes and best practices.
  • Trains new personnel in relevant processes and systems.
  • Utilizes local knowledge to assist in identifying and developing new sites.

Qualifications:

A high school diploma or equivalent is required, with relevant formal academic or vocational qualifications preferred. A Bachelor's degree is advantageous. Previous experience that equips the candidate with the necessary knowledge, skills, and abilities for the role is essential (typically 0 to 1 year). In some instances, a combination of appropriate education, training, and/or directly related experience may be deemed sufficient to meet the role's requirements.

Skills and Competencies:

The ideal candidate will possess the ability to work effectively in both team settings and independently as needed. Strong organizational skills and attention to detail are crucial, along with the capability to manage multiple tasks efficiently. A demonstrated ability to analyze project-specific data and systems for accuracy and efficiency is essential, alongside a strong customer focus.

Flexibility to adjust priorities in response to changing project timelines is necessary. Candidates should have a solid understanding of applicable country regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs related to all nonclinical and clinical aspects of project implementation, execution, and closeout.

Proficiency in English and local languages as required, along with strong computer skills, particularly in MS Office (Word, Excel, and PowerPoint), is expected. The ability to master all clinical trial database systems is essential.

Candidates should be self-motivated, possess a positive attitude, and demonstrate effective interpersonal skills. Strong oral and written communication skills, along with sound judgment and decision-making abilities, are critical. The capacity to accurately follow project work instructions and negotiate effectively is also important.

Independent thinking and the ability to manage risk appropriately are key attributes for success in this role.