Clinical Trial Coordinator

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

📋 Description

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

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

• Complete assigned tasks punctually, adhering to budget constraints and quality standards.

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

• Process trial documentation, carry out eTMF reviews, distribute communications, and generate reports.

• Analyze and reconcile study metrics along with findings reports.

• Manage and distribute Investigator Site Files, pharmacy binder materials, and non-clinical study supplies.

• Assist with the preparation of study-specific translation materials and oversee translation quality control.

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

• Facilitate scheduling of client/internal meetings and track local regulatory documents.

• Support risk-based monitoring initiatives and study documentation systems.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers and assist with regulatory submissions.

• Acquire site-selection documents directly from sites.

• Prepare packages for regulatory compliance reviews.

• Coordinate site start-up activities with internal departments.

• Complete Site Interest Plans and gather associated investigator/site documentation.

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

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

• Collaborate with team members and clinical staff regarding site issues, risks, and deadlines.

• Develop and maintain efficient plans for site contact and follow-up.

• Provide local expertise on site capacity, experience, and tiering.

• Address investigator inquiries with Global Investigator Services and uphold account/contact information.

• Contribute to global feasibility processes and best practices.

• Train new staff on processes and systems.

• Utilize local knowledge to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

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

• An equivalent combination of appropriate education, training, and/or directly related experience may be acceptable.

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

• Strong organizational skills with a keen attention to detail.

• Capability to analyze project-specific data and systems.

• Strong focus on customer service.

• Ability to adjust workload priorities based on shifting timelines.

• Working knowledge of relevant country regulations, ICH Good Clinical Practices, organizational/client SOPs, and WPDs.

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

• Proficient in MS Office applications, including Word, Excel, and PowerPoint.

• Ability to learn and master clinical trial database systems.

• Successful completion of the organization's clinical training program is required.

• Effective oral and written communication skills.

• Strong judgment and decision-making abilities.

• Ability to accurately follow project work instructions.

• Negotiation skills are an asset.

• Ability to manage risks and escalate them appropriately.

🏝️ Benefits

• Fully remote work setup.

• Full-time employment status.

• Standard work schedule from Monday to Friday.

• Potential for occasional travel.

• Access to a clinical training program.