Clinical Trial Coordinator

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

📋 Description

• Coordinate, manage, and execute assigned trial activities as outlined in the task matrix.

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

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

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

• Maintain documentation specific to the study, including team lists, training requirements, system access, activity plans, and eTMF records.

• Provide support for GoBalto and eTMF systems.

• Assist with risk-based monitoring efforts.

• Process trial documents, conduct eTMF reviews, manage mass mailings, and supply documents and reports to internal team members.

• Organize and schedule client and internal meetings, and prepare meeting minutes.

• Review and monitor local regulatory documents.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports, assisting in resolving site documentation issues.

• Maintain vendor tracking systems.

• Compile, coordinate, and distribute materials for the Investigator Site File and Pharmacy binder, as well as non-clinical study supplies to sites.

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

• Attend kick-off meetings and take notes as needed.

• Provide administrative and technical support to the Project Team.

• Act as a study lead or cross-functional liaison when necessary.

• Support onboarding by acting as a buddy and training new staff when required.

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

• Occasional travel to site locations may be required.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience that demonstrates the knowledge, skills, and abilities necessary for the job, equivalent to at least 4 years.

• Ability to work collaboratively in a team or independently as the situation demands.

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

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

• Strong focus on customer service.

• Ability to adapt and reprioritize workload to provide efficient support in response to changing project timelines.

• Proven capability to maintain a thorough understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution, and closeout.

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

• Strong presentation skills.

• Proficient computer skills, including mastery of MS Office (Word, Excel, and PowerPoint), and the ability to learn and master all clinical trial database systems.

• Ability to successfully complete the PPD clinical training program.

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

• In certain cases, a combination of education, training, and/or directly related experience may be accepted as sufficient.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Generous paid time off and flexible work arrangements.

• Support for continuing education and training programs.