Clinical Trial Coordinator

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

📋 Description

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

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

• Ensure tasks are completed promptly, within budget, and uphold high-quality standards.

• Proactively communicate project risks to project leaders.

• Provide support for Activate, eTMF, and other clinical trial systems, ensuring databases are up-to-date.

• Process documents for the Client eTMF, conduct eTMF reviews, manage mailings and communications, and generate reports.

• Analyze and reconcile study metrics and findings reports.

• Assist in resolving documentation findings from sites.

• Organize and distribute materials for the Investigator Site File and Pharmacy binders, as well as non-clinical study supplies.

• Support the translation of materials and quality control for translations.

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

• Conduct on-site feasibility visits when applicable for Asia Pacific roles.

• Assist with scheduling client and internal meetings.

• Review and monitor local regulatory documents.

• Support RBM activities along with study-specific documentation and systems.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers.

• Assist with regulatory submissions.

• Obtain site-selection documents directly from sites.

• Prepare regulatory compliance review packages.

• Collaborate with internal departments to align site start-up activities with the activation critical path.

• Complete Site Interest Plans in CTMS and gather related investigator and site personnel documents when necessary.

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

• Review survey data for logical, complete, and relevant responses.

• Collaborate with teammates and clinical personnel regarding site issues and risks.

• Maintain an efficient site-contact and follow-up plan, escalating non-compliance as needed.

• Provide local expertise on site capacity and experience, and recommend additional sites.

• Liaise with Global Investigator Services to address investigator queries and maintain account and contact information.

• Contribute to global feasibility processes and best practices.

• Train new personnel in processes and systems.

• Leverage local knowledge to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor’s degree preferred.

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

• A suitable combination of education, training, and/or directly related experience will be considered.

• Capability to work independently or collaboratively within a team.

• Strong organizational skills coupled with attention to detail.

• Ability to manage multiple tasks effectively and efficiently.

• Proficiency in analyzing project-specific data and systems.

• Strong focus on customer service.

• Flexibility to reprioritize workload as necessary.

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

• Good command of the English language and grammar, with proficient local language skills as required.

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

• Ability to learn and master clinical trial database systems.

• Capability to complete the organization’s clinical training program.

• Effective oral and written communication skills.

• Strong judgment and decision-making abilities.

• Ability to strictly follow project work instructions.

• Negotiation skills.

• Proficient in managing risk and performing risk escalation as needed.

• Occasional travel may be necessary.

• Occasional driving to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.