Clinical Trial Coordinator II

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

📋 Description

• Coordinate, manage, and execute assigned trial activities as per the task matrix.

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

• Ensure that assigned tasks are completed punctually, within budget, and to a high standard of quality.

• Process documents sent to the client eTMF, conduct eTMF reviews, communicate with stakeholders, and provide necessary documents and reports.

• Review and monitor local regulatory documents.

• Analyze and reconcile study metrics and findings reports.

• Maintain vendor trackers.

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

• Support the development of study-specific translation materials and ensure translation quality control.

• Provide technical and administrative project support in collaboration with internal teams and departments.

• Keep accurate trial status information updated in databases.

• Develop and sustain relationships with client local affiliates when applicable.

• Conduct on-site feasibility visits as necessary (Asia Pacific only).

• Train new personnel on processes and systems.

• Maintain study documentation, team lists, training requirements, system access, and activity plans.

• Provide system support for Activate and eTMF while assisting RBM activities.

• Transmit documents to clients and centralized IRB/IEC.

• Attend kick-off meetings and take notes when needed.

• Schedule and organize client/internal meetings and prepare minutes accordingly.

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

• Assist with the review packages for regulatory compliance and regulatory submissions.

• Obtain site-selection documents and compile site lists from both internal and external sources.

• Maintain contact details for investigators and site staff in company systems.

• Complete Site Interest Plans in CTMS and document site communications and follow-ups.

• Review survey data for logical consistency, completeness, and relevance of responses.

• Work collaboratively with teammates to meet project deadlines and communicate site issues and risks.

• Conduct phone interviews with physicians and site personnel to facilitate trial optimization.

• Liaise with Global Investigator Services to address investigator queries.

• Contribute to global strategic feasibility processes and best practices.

⛳️ Requirements

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

• Prior experience providing the knowledge, skills, and abilities necessary for the role (equivalent to at least 2 years).

• Bachelor’s degree is preferred.

• Ability to work effectively as part of a team or independently.

• Strong organizational skills coupled with meticulous attention to detail.

• Capability to analyze project-specific data/systems.

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

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

• Proficiency in MS Office (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.

• Excellent interpersonal, presentation, negotiation, organizational, and planning skills.

• Basic knowledge of medical/therapeutic areas and medical terminology.

• Fundamental understanding of local health systems.

• Familiarity with GCP and applicable SOPs.

• Ability to operate effectively in a matrix environment.

• Skill in managing risk and appropriately escalating issues.

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

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.