Clinical Trial Coordinator

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Offer both administrative and technical assistance to the Project Team.

• Facilitate audit readiness by ensuring that files are evaluated in accordance with organizational SOPs and departmental guidance.

• Provide administrative support for site activation efforts and assist in the formulation of critical paths for site activation.

• Create and assess site lists for feasibility activities, providing local insights into site tiering.

• Coordinate, manage, and execute assigned trial activities in line with the task matrix.

• Conduct reviews of department, internal, country, and investigator files, documenting findings accordingly.

• Ensure that assigned tasks are completed punctually, within budget, and to a high-quality standard; communicate any risks to project leads.

• Offer system support for Activate and eTMF while ensuring databases are kept up-to-date.

• Process and review eTMF documents, distribute communications, and supply documents and reports to internal team members.

• Analyze and reconcile study metrics and findings reports.

• Coordinate materials for Investigator Site Files and Pharmacy binders, along with non-clinical study supplies.

• Assist with study-specific translation materials and manage translation quality control.

• Review and monitor local regulatory documents and support regulatory submissions.

• Organize client and internal meetings as necessary.

• Maintain study documentation, team lists, training requirements, system access, activity plans, vendor trackers, and contact information.

• Engage directly with sites to obtain site-selection documents and assist with site interest plans and survey responses.

• Prepare packages for regulatory compliance review.

• Collaborate with internal departments to synchronize site start-up activities with the activation critical path.

• Communicate with clinical personnel regarding site-related issues and risks; escalate instances of non-compliance.

• Serve as a local expert on site capacity and experience, contributing to the identification and development of new sites.

• Liaise with Global Investigator Services to address investigator inquiries.

• Contribute to global strategic feasibility processes and best practices.

• Train new personnel on processes and systems.

⛳️ Requirements

• High school diploma or equivalent, along with relevant formal academic or vocational qualifications.

• Previous experience providing the necessary knowledge, skills, and abilities to perform the role (equivalent to 0 to 1 year).

• In certain cases, a combination of appropriate education, training, and/or directly related experience may be deemed sufficient to meet the role's requirements.

• Ability to work collaboratively within a team or independently as required.

• Strong organizational skills and attention to detail, with a proven capability to manage multiple tasks efficiently and effectively.

• Proven ability to effectively analyze project-specific data and systems to ensure accuracy and efficiency.

• Strong focus on customer service.

• Flexibility to adjust workload priorities to meet evolving project timelines.

• Proven capacity to acquire and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical and clinical aspects of project implementation, execution, and closeout.

• Proficient English language skills and local language skills as necessary.

• Solid computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and capable of learning and mastering all clinical trial database systems.

• Ability to successfully complete the organization's clinical training program.

• Self-motivated with a positive attitude and strong interpersonal skills.

• Effective oral and written communication abilities.

• Essential judgment and decision-making skills.

• Capable of accurately adhering to project work instructions.

• Good negotiation skills.

• Independent thinker.

• Ability to manage risk and perform appropriate risk escalation.

• Occasional driving to site locations; potential for occasional travel required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.