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 readiness by conducting scheduled file reviews in accordance with SOPs and departmental guidelines.

• Provide administrative support for site activation efforts and aid in developing critical paths for site activation.

• Create and evaluate site lists for feasibility tasks and offer local insights for site tiering.

• Coordinate, manage, and fulfill assigned trial activities as per the task matrix.

• Execute reviews of departmental, internal, country, and investigator files, documenting findings.

• Complete assigned tasks punctually, within budget, and adhering to quality standards; notify project leads of potential risks.

• Support Activate and eTMF systems, ensuring databases are kept up-to-date.

• Process documents sent to client eTMF, conduct eTMF reviews, distribute communications, and provide reports.

• Analyze and reconcile study metrics and findings reports.

• Assist with materials for the Investigator Site File and Pharmacy binder, as well as non-clinical study supplies.

• Aid in translation materials and maintain quality control for translations.

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

• Conduct on-site feasibility visits as needed for Asia Pacific roles.

• Assist in scheduling client and internal meetings.

• Review and monitor local regulatory documents.

• Support RBM activities and documentation related to studies and systems.

• Forward documents to clients and centralized IRB/IEC.

• Maintain vendor trackers.

• Assist with regulatory submissions and activities related to site start-up.

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

• Prepare packages for regulatory compliance reviews.

• Coordinate with internal departments to ensure alignment of site start-up activities with the activation critical path.

• Complete Site Interest Plans and gather relevant investigator/site documents where applicable.

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

• Review survey data for logical, complete, and relevant responses.

• Work collaboratively with teammates and clinical personnel regarding site-related issues and risks.

• Maintain effective site contact and follow-up strategies while addressing non-compliance issues.

• Act as a local authority on site capacity and experience, 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 best practices.

• Train new personnel in processes and systems.

• Utilize local knowledge to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience of approximately 0 to 1 year is required.

• Equivalent education, training, and/or related experience may be considered.

• Capability to work both independently and as part of a team.

• Strong organizational skills with a keen attention to detail.

• Ability to manage multiple tasks efficiently and effectively.

• Proficient in analyzing project-specific data/systems for accuracy and efficiency.

• Strong focus on customer service.

• Flexibility to adjust workload priorities as required.

• Familiarity with relevant country regulations, ICH Good Clinical Practices, organizational/client SOPs, and WPDs.

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

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

• Ability to learn and master clinical trial database systems.

• Capable of completing the organization's clinical training program.

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

• Effective in both oral and written communication.

• Possess sound judgment and decision-making abilities.

• Ability to accurately adhere to project work instructions.

• Good negotiation skills.

• Independent thinker.

• Ability to manage risks and escalate issues appropriately.

• Occasional travel to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.