Clinical Research Coordinator for LATAM Operations
hace 2 semanas
Overview:
The Clinical Trial Coordinator plays a vital role in providing both administrative and technical assistance to the Project Team. This position is essential for maintaining audit readiness by ensuring that all files are meticulously reviewed in accordance with the organization's Standard Operating Procedures (SOP) and departmental guidelines. The coordinator will support site activation efforts and contribute to the development of a streamlined critical path for rapid site activations within assigned projects.
Key Responsibilities:
Coordinate and oversee trial activities as per the task matrix, tailored to specific roles (Central or Local). Conduct thorough reviews of department, internal, country, and investigator files, documenting findings in the appropriate systems. Ensure timely execution of allocated tasks, adhering to budget constraints and maintaining high-quality standards. Proactively communicate any potential risks to project leads. Provide system support for tools such as Activate & eTMF, ensuring that databases are consistently updated. Manage administrative duties for assigned trials, including the prompt processing of documents sent to the Client (e)TMF, conducting (e)TMF reviews, and distributing communications as necessary. Analyze and reconcile study metrics and findings reports, assisting in the clarification and resolution of documentation-related issues. Facilitate the coordination, compilation, and distribution of Investigator Site Files (ISF) and Pharmacy binder materials. Support the preparation of study-specific translation materials and perform quality control on translations when requested. Maintain an up-to-date understanding of SOPs, client directives, and current regulatory guidelines relevant to the services provided. Conduct on-site feasibility visits where applicable. Assist in scheduling client and internal meetings as needed. Review and track local regulatory documents. Provide system support for Activate & eTMF and assist with Risk-Based Monitoring (RBM) activities. Help maintain study-specific documentation and systems, including tracking project-specific training requirements and managing system access. Transmit documents to clients and centralized Institutional Review Boards (IRB)/Independent Ethics Committees (IEC). Maintain vendor trackers and support the start-up team in regulatory submissions. Collaborate directly with sites to gather necessary documents for site selection. Assist the project team in preparing regulatory compliance review packages. Coordinate with internal departments to ensure alignment of site start-up activities with the critical path for site activation. Document all communications and follow-ups related to site contacts and survey responses in real time. Review survey data to ensure logical and complete responses. Work collaboratively with team members to meet project deadlines and communicate site issues and risks effectively. Develop and implement an efficient plan for site contact and follow-up, ensuring compliance and escalating concerns as necessary. Act as a local expert on site capacity and experience, gathering insights to recommend additional sites. Liaise with Global Investigator Services to address investigator queries promptly. Contribute to the establishment and dissemination of global strategic feasibility processes and best practices. Train new personnel on processes and systems. Utilize local knowledge to aid in the identification and development of new sites.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 knowledge, skills, and abilities for the role is essential. In certain cases, a combination of education, training, and directly related experience may be considered sufficient.
Skills and Competencies:
The ideal candidate will demonstrate the ability to work both independently and as part of a team. Strong organizational skills and attention to detail are crucial, along with the capacity to manage multiple tasks efficiently. A customer-focused mindset, flexibility in workload prioritization, and a solid understanding of applicable regulations and clinical practices are essential. Proficiency in English and local languages, as well as strong computer skills, particularly in MS Office and clinical trial databases, are required. The candidate should possess effective communication skills, good judgment, and the ability to manage risks appropriately.
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