Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Aid in audit preparedness through timely file evaluations in accordance with SOPs and departmental guidelines.

• Offer administrative support for site activation tasks and critical-path planning.

• Create and assess site lists for feasibility studies and contribute to site tiering efforts.

• Manage, supervise, and execute assigned trial responsibilities as outlined in the task matrix.

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

• Ensure that assigned duties are fulfilled punctually, within budget constraints, and meet quality benchmarks.

• Provide assistance for Activate, eTMF, and other clinical trial platforms.

• Process trial documentation, perform eTMF evaluations, disseminate communications, and generate reports.

• Analyze and reconcile research metrics and findings reports.

• Coordinate and distribute Investigator Site File and Pharmacy binder materials, along with study supplies.

• Assist with study-specific translation documents and oversee translation quality control.

• Assess and track local regulatory documents.

• Support RBM initiatives and maintain study documentation.

• Transmit documents to clients and centralized IRB/IEC.

• Maintain vendor trackers and facilitate regulatory submissions.

• Acquire site-selection documents directly from the sites.

• Assemble regulatory compliance review packages.

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

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

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

• Evaluate survey data for thoroughness, logic, and relevance.

• Work with colleagues and clinical staff on site-related issues, risks, and deadlines.

• Organize site contact and follow-up strategies, escalating any concerns or non-compliance issues.

• Act as a local authority on site capacity and experience, recommending additional sites as needed.

• Collaborate with Global Investigator Services to address investigator inquiries and maintain up-to-date contact information.

• Contribute to global feasibility processes and best practices.

• Train new employees on processes and systems.

• Share local expertise to identify and cultivate new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

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

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

• Capability to work collaboratively within a team or independently.

• Strong organizational skills and keen attention to detail.

• Ability to analyze project-specific data and systems.

• Strong focus on customer service.

• Flexibility to adjust priorities as needed.

• Familiarity with relevant country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

• Proficiency in English grammar and language skills, along with necessary local language skills.

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

• Willingness to learn clinical trial database systems.

• Ability to complete the organization's clinical training program.

• Strong oral and written communication abilities.

• Sound judgment and decision-making capabilities.

• Skill in accurately following project work instructions.

• Good negotiation skills.

• Ability to manage risks and perform appropriate risk escalation.

• Occasional driving to site locations and potential for infrequent travel.

🏝️ Benefits

• Flexible fully remote work arrangement.

• Standard Monday–Friday work schedule.