Clinical Trial Coordinator

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

📋 Description

• Depending on the designated role (Central or Local), coordinates, manages, and finalizes functions 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 designated tasks are completed punctually, within budget, and to a high standard of quality. Proactively informs project leads and line manager of any potential risks as necessary.

• Aids in the upkeep of study-specific documentation and provides global support with various systems, tools, and trackers, including but not limited to: study team lists, tracking project-specific training needs, managing system access for organizations/vendors/clients, and monitoring project-level activity plans in the appropriate system. Ensures that the (e)TMF is current by adhering to file review schedules and documenting findings in the appropriate system.

• Offers system support (e.g., GoBalto & eTMF).

• Assists with Risk-Based Monitoring (RBM) activities.

• Carries out administrative duties for assigned trials, including the timely processing of documents sent to the Client (e)TMF, conducting (e)TMF reviews, performing mass mailings, and providing documents and reports to internal team members as needed.

• Aids in scheduling and organizing client and/or internal meetings, ensuring completion of related meeting minutes.

• Reviews and monitors local regulatory documents.

• Sends documents to clients and centralized IRB/IEC.

• Analyzes and reconciles study metrics and findings reports, assisting in the clarification and resolution of findings related to site documentation.

• Maintains vendor trackers.

• Assists in the coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials, as well as non-clinical study supplies to sites.

• Aids with study-specific translation materials and translation quality control upon request.

• May attend kickoff meetings and take notes when necessary.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Previous experience that provides the necessary knowledge, skills, and abilities to perform the job effectively (equivalent to at least 4 years).

• Ability to work collaboratively in a team or independently as needed.

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

• Demonstrated ability to accurately analyze project-specific data/systems to ensure precision and efficiency.

• Strong customer focus.

• Proven flexibility and adaptability to reorganize workload and provide efficient support in response to changing project timelines.

• Demonstrated capability to acquire and maintain a solid working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution, and closeout.

• Excellent proficiency in English language and grammar, alongside proficient local language skills as required.

• Good presentation abilities.

• Proficient computer skills, with expertise in MS Office (Word, Excel, and PowerPoint) and the ability to learn and master all clinical trial database systems.

• Capability to successfully complete the PPD clinical training program.

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

🏝️ Benefits

• Competitive salary.

• Flexible working hours.

• Professional development budget.

• Home office setup allowance.

• Global team events.