Clinical Trial Coordinator

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

📋 Description

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

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

• Ensure that assigned tasks are completed punctually, within budget, and to a high-quality standard.

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

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

• Analyze and reconcile metrics and reports related to the study.

• Coordinate and distribute materials for the Investigator Site File, pharmacy binder, and study supplies.

• Assist in the preparation of translation materials and ensure translation quality control.

• Maintain an up-to-date knowledge of SOPs, client directives, and regulatory guidelines.

• Support scheduling for client and internal meetings, track regulatory documents, and assist with RBM activities.

• Keep study documentation, training records, system access, team lists, and activity plans organized.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers and assist with regulatory submissions.

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

• Prepare packages for regulatory compliance review.

• Coordinate with internal departments to synchronize site start-up activities.

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

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

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

• Work with team members and clinical personnel to address site issues and risks.

• Ensure adherence to site-contact plans and escalate any concerns or non-compliance.

• Provide local expertise regarding site capacity and experience, and recommend additional sites as needed.

• Liaise with Global Investigator Services to resolve investigator inquiries and maintain updated contact information.

• Contribute to global feasibility processes and best practices.

• Train new personnel on processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

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

• A Bachelor's degree is an advantage.

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

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

• Ability to learn and master clinical trial database systems.

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

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

• Ability to accurately follow project work instructions.

• Skill in managing risks and performing appropriate risk escalation.

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

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment opportunity.

• Standard Monday–Friday work schedule.

• Potential for occasional travel.

• Comprehensive training and onboarding support.