Clinical Trial Coordinator

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

📋 Description

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

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

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

• Provide system support for Activate and eTMF, ensuring system databases are up-to-date.

• Process documents for the Client (e)TMF, conduct (e)TMF reviews, distribute communications, and supply documents and reports.

• Analyze and reconcile study metrics and findings reports; assist in resolving site documentation issues.

• Coordinate materials for the Investigator Site File, Pharmacy binder, and non-clinical study supplies.

• Support the translation of study-specific materials and ensure quality control of translations.

• Stay informed about SOPs, client directives, and regulatory guidelines.

• Assist with scheduling client/internal meetings and tracking local regulatory documents.

• Support RBM activities along with study documentation, training requirements, system access, and project activity plans.

• Send documents to the client and centralized IRB/IEC.

• Maintain vendor trackers and assist with regulatory submissions.

• Collaborate directly with sites to obtain site-selection documents.

• Prepare packages for regulatory compliance reviews.

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

• Complete Site Interest Plans in CTMS and gather necessary investigator/site personnel documents.

• Document site communications, follow-ups, and survey responses in real time.

• Review survey data for logical consistency, completeness, and relevance.

• Collaborate with team members and clinical personnel regarding deadlines, site-related issues, and risks.

• Maintain an effective site-contact and follow-up plan; escalate concerns and instances of non-compliance.

• Serve as a local expert on site capacity and experience; suggest additional sites and assist with local site tiering.

• Liaise with Global Investigator Services to resolve queries from investigators and maintain account/contact information.

• Contribute to global strategic feasibility processes and best practices.

• Train new personnel in relevant processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Previous experience ranging from 0 to 1 year is comparable.

• Equivalency may be considered based on appropriate education, training, and/or directly related experience.

• Ability to work effectively in a team or independently.

• Strong organizational skills and meticulous attention to detail; capable of managing multiple tasks efficiently.

• Ability to analyze project-specific data/systems for accuracy and efficiency.

• Strong focus on customer service.

• Flexibility to adjust workload priorities as needed.

• Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

• Proficient in English language and grammar, along with necessary local language skills.

• Proficient in MS Office (Word, Excel, and PowerPoint) and capable of mastering clinical trial database systems.

• Ability to complete the organization’s clinical training program.

• Effective oral and written communication skills.

• Essential judgment and decision-making abilities.

• Ability to accurately follow project work instructions.

• Good negotiation skills.

• Ability to manage risks and perform appropriate risk escalation.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.