Clinical Trial Coordinator

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

📋 Description

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

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

• Ensure timely completion of assigned tasks while adhering to budget constraints and maintaining high-quality standards.

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

• Process and review trial documents, manage communications, and generate reports for internal teams.

• Analyze and reconcile study metrics along with findings reports.

• Assist in preparing Investigator Site File and Pharmacy binder materials, as well as study supplies.

• Support translation materials and oversee translation quality control.

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

• Conduct on-site feasibility visits as necessary for Asia Pacific roles.

• Aid in scheduling client and internal meetings and track local regulatory documents.

• Facilitate risk-based monitoring activities and maintain study-specific documentation systems.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers and assist with regulatory submissions.

• Collaborate directly with sites to gather site-selection documents.

• Prepare packages for regulatory compliance reviews.

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

• Complete Site Interest Plans in CTMS and gather necessary investigator and site documents as applicable.

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

• Review survey data to ensure logical, complete, and relevant responses.

• Work alongside teammates and clinical personnel to address site issues, risks, and deadlines.

• Ensure that plans for site contact and follow-up are executed, escalating concerns or instances of non-compliance as needed.

• Provide local expertise on site capacity and experience, recommending additional sites when appropriate.

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

• Contribute to global feasibility processes and promote best practices.

• Train new personnel on processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

• High School diploma or equivalent, along with relevant formal academic or vocational qualifications.

• Bachelor's degree is preferred.

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

• Consideration may be given to equivalency through a combination of appropriate education, training, and/or directly related experience.

• Capability to work effectively within a team or independently.

• Excellent organizational skills coupled with strong attention to detail.

• Ability to analyze project-specific data and systems.

• Strong focus on customer service.

• Flexibility to adjust workload priorities as needed.

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

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

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

• Ability to learn and master clinical trial database systems.

• Capacity to successfully complete the organization's clinical training program.

• Strong oral and written communication skills.

• Essential judgment and decision-making abilities.

• Capability to accurately follow project work instructions.

• Good negotiation skills.

• Ability to manage risks and appropriately escalate issues.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.