Clinical Trial Coordinator

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

📋 Description

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

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

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

• Communicate any project risks to project leads and the line manager.

• Maintain study documentation, team lists, training trackers, system access, and project activity plans.

• Keep the electronic Trial Master File current and provide support for GoBalto and eTMF systems.

• Assist in risk-based monitoring activities.

• Process trial documents, conduct eTMF reviews, manage mass mailings, and generate reports.

• Schedule and organize client/internal meetings and prepare minutes of these meetings.

• Review and monitor local regulatory documents.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Maintain vendor trackers.

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

• Support the creation of study-specific translation materials and oversee translation quality control.

• Serve as a study lead or cross-functional liaison when assigned.

• Assist new staff during the onboarding process and provide training as necessary.

• Contribute to departmental and cross-functional process improvement initiatives.

⛳️ Requirements

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

• Prior experience that provides the knowledge, skills, and abilities to perform the job, equivalent to at least 4 years.

• Ability to work collaboratively in a team or independently as required.

• Strong organizational skills and meticulous attention to detail, with a proven capability to manage multiple tasks efficiently and effectively.

• Demonstrated ability to analyze project-specific data/systems effectively to ensure accuracy and efficiency.

• Strong focus on customer service.

• Proven flexibility and adaptability to reprioritize workload and accommodate changing project timelines.

• Working knowledge of relevant Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.

• Excellent command of the English language and grammar, along with proficient local language skills as necessary.

• Strong presentation skills.

• Proficient in MS Office (including Word, Excel, and PowerPoint) with the capability to master clinical trial database systems.

• Ability to successfully complete the PPD clinical training program.

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

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.