Clinical Trial Coordinator

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

📋 Description

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

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

• Ensure timely completion of assigned tasks within budget and maintaining high-quality standards.

• Proactively communicate project risks to project leads.

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

• Process documents for client eTMF, conduct eTMF reviews, disseminate communications, and generate reports.

• Analyze and reconcile study metrics and findings reports.

• Assist with the preparation of Investigator Site File and Pharmacy binder materials, as well as non-clinical study supplies.

• Support translation materials and ensure translation quality control.

• Maintain an understanding of SOPs, client directives, and regulatory guidelines.

• Assist with scheduling client/internal meetings and tracking local regulatory documents.

• Provide support for RBM activities and the maintenance of study documentation/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.

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

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

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

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

• Collaborate with teammates and clinical personnel to address 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, recommending additional sites when appropriate.

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

• Contribute to global feasibility processes and best practices.

• Train new personnel on processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Previous experience of 0 to 1 year in a comparable role.

• Equivalency may be considered through a combination of appropriate education, training, and/or directly related experience.

• Ability to work independently as well as collaboratively within a team.

• Strong organizational skills with keen attention to detail.

• Capability to analyze project-specific data and systems.

• Strong focus on customer service.

• Flexibility to reprioritize workload as necessary.

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

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

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

• Ability to learn clinical trial database systems.

• Capability to complete the clinical training program of the organization.

• Effective oral and written communication skills.

• Good judgment and decision-making abilities.

• Ability to accurately follow project work instructions.

• Negotiation skills.

• Ability to manage risk and perform appropriate risk escalation.

• Potential for occasional travel and necessary drives to site locations.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday to Friday work schedule.