Clinical Trial Coordinator

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

📋 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 insights.

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

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

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

• Provide support for systems, including GoBalto and eTMF.

• Assist in risk-based monitoring activities.

• Process documents for the client eTMF, conduct eTMF reviews, manage mass mailings, and generate reports.

• Schedule and organize client and internal meetings, and complete meeting minutes.

• Review and monitor local regulatory documents.

• Transmit documents to the client and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Aid in clarifying and resolving site documentation findings.

• Maintain vendor trackers.

• Coordinate, compile, and distribute materials for the Investigator Site File and Pharmacy binder, along with non-clinical study supplies.

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

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

• Serve as a cross-functional liaison and may take on the role of a study lead.

• Support onboarding as a buddy and provide training to new staff as required.

• 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 providing the necessary knowledge, skills, and abilities to perform this role, equivalent to at least 4 years.

• An equivalency made up of a combination of appropriate education, training, and/or directly related experience may be deemed sufficient.

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

• Strong organizational capabilities and meticulous attention to detail.

• Demonstrated ability to manage multiple tasks efficiently and effectively.

• Proven capability to analyze project-specific data/systems for accuracy and efficiency.

• Strong focus on customer satisfaction.

• Flexibility and adaptability to adjust workload priorities and meet evolving project timelines.

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

• Excellent English language proficiency and grammar skills, along with proficient local language skills as required.

• Good presentation abilities.

• Proficient computer skills; expertise in MS Office (Word, Excel, and PowerPoint).

• Capability to acquire knowledge of and master clinical trial database systems.

• Ability to successfully complete the PPD clinical training program.

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

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

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.