Clinical Trial Coordinator

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

📋 Description

• Offer administrative and technical assistance to project teams.

• Facilitate audit readiness through scheduled department, internal, country, investigator, and eTMF file evaluations.

• Assist in site activation efforts and the development of critical-path activities.

• Coordinate, manage, and finalize assigned trial tasks in accordance with task matrices.

• Conduct file reviews and document findings in the appropriate systems.

• Ensure that assigned responsibilities are accomplished punctually, within budget, and to high-quality standards.

• Maintain Activate, eTMF, CTMS, vendor trackers, study documentation, training records, system access, and activity plans.

• Process and send documents to client eTMF and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

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

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

• Aid in scheduling client and internal meetings.

• Support tracking of regulatory documents and submissions.

• Acquire site-selection documents directly from sites.

• Assist with regulatory compliance review packages and the coordination of site start-up activities.

• Complete Site Interest Plans and gather related investigator/site documents when necessary.

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

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

• Collaborate with colleagues and clinical personnel to manage site issues, risks, deadlines, and follow-up strategies.

• Provide local expertise on site capacity, experience, tiering, and the identification of new sites.

• Serve as a liaison with Global Investigator Services to address investigator queries and maintain account/contact details.

• Contribute to global feasibility processes and promote best practices.

• Train new staff on processes and systems.

• Conduct on-site feasibility visits as applicable in the Asia Pacific region.

⛳️ Requirements

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

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

• A Bachelor's degree is advantageous.

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

• Proficient English language and grammar skills, with local language proficiency as needed.

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

• Ability to comprehend and master clinical trial database systems.

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

• Awareness of relevant country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

• Ability to work autonomously or as part of a team.

• Strong organizational, analytical, communication, negotiation, judgment, decision-making, and risk-management skills.

• Capability to accurately follow project work instructions.

• Occasional driving to site locations and potential travel may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Potential for occasional travel.

• Training and onboarding support provided.

• Opportunity to act as a buddy during onboarding and provide training to new staff.