FSP Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Facilitate audit preparedness through regular file reviews in accordance with SOPs and departmental guidelines.

• Offer administrative support for site activation processes and aid in the development of site activation critical paths.

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

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

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

• Ensure that assigned tasks are accomplished on schedule, within budget, and meet quality standards; communicate risks to project leaders.

• Provide system support for Activate and eTMF while maintaining up-to-date databases.

• Handle client eTMF documents, perform eTMF reviews, disseminate communications, and provide reports and documents.

• Analyze and reconcile study metrics and findings reports.

• Organize Investigator Site File and Pharmacy binder materials, along with non-clinical study supplies.

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

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

• Aid in scheduling client and internal meetings.

• Review and monitor local regulatory documents.

• Support RBM activities and documentation specific to the study and related systems.

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

• Maintain vendor trackers.

• Assist with regulatory submissions and the collection of site selection documents.

• Prepare packages for regulatory compliance review.

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

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

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

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

• Work with teammates and clinical staff to address site issues and risks.

• Maintain site contact and follow-up plans, escalating concerns or instances of non-compliance.

• Provide local insight on site capacity and expertise, recommending additional sites as needed.

• Liaise with Global Investigator Services to address investigator inquiries and maintain account/contact information.

• Contribute to global feasibility processes and share best practices.

• Train new personnel on processes and systems.

• Leverage local knowledge to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience ranging from 0 to 1 year in a comparable role.

• Equivalency through a combination of suitable education, training, and/or directly related experience may be considered.

• Capability to work collaboratively in a team or independently.

• Strong organizational skills and keen attention to detail.

• Proficiency in managing multiple tasks efficiently and effectively.

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

• Strong focus on customer service.

• Flexibility to adjust workload priorities.

• Familiarity with applicable Country Regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs.

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

• Competence in MS Office (Word, Excel, and PowerPoint).

• Ability to learn and master clinical trial database systems.

• Capability to successfully complete the organization’s clinical training program.

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

• Effective oral and written communication abilities.

• Essential judgment and decision-making capabilities.

• Ability to accurately adhere to project work instructions.

• Strong negotiation skills.

• Independent critical thinking.

• Ability to manage risks and execute appropriate risk escalation measures.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday to Friday work schedule.

• Potential for occasional travel.

• Training provided for new personnel, including a clinical training program.