Clinical Trial Coordinator

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

📋 Description

• Deliver administrative and technical assistance to the Project Team.

• Facilitate audit readiness by conducting scheduled file reviews in accordance with SOPs and departmental guidelines.

• Offer administrative support for site activation procedures and critical-path development.

• Create and evaluate site lists for feasibility studies and assist in local site tiering.

• Organize, supervise, and fulfill assigned trial activities as outlined in the task matrix.

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

• Ensure tasks are completed punctually, within budget, and meet quality standards; communicate any risks to project leads.

• Provide system support in Activate and eTMF while keeping databases updated.

• Process documents for Client eTMF, conduct eTMF reviews, distribute communications, and generate reports.

• Analyze and reconcile study metrics and findings reports.

• Coordinate and distribute Investigator Site Files, Pharmacy binder materials, and non-clinical study supplies.

• Assist with translation materials and maintain translation quality control.

• Organize client and internal meetings as required.

• Review and monitor local regulatory documents.

• Support risk-based monitoring initiatives.

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

• Transmit documents to clients and centralized IRB/IEC.

• Keep vendor trackers updated.

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

• Collaborate with sites to obtain site-selection documents.

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

• Complete Site Interest Plans in CTMS and gather relevant investigator/site personnel documents.

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

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

• Collaborate with teammates and clinical personnel concerning deadlines, site issues, and risks.

• Ensure adherence to site-contact plans and escalate any concerns or non-compliance issues.

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

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

• Contribute to global feasibility processes and best practices.

• Train new personnel on processes and systems.

• Leverage local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Previous experience ranging from 0 to 1 year is preferred.

• A Bachelor's degree is preferred.

• Ability to collaborate in a team environment or work independently.

• Strong organizational skills with keen attention to detail.

• Capability to analyze project-specific data and systems accurately and efficiently.

• Strong customer service orientation.

• Flexibility to adjust and reprioritize workload as necessary.

• Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.

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

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

• Ability to learn and master clinical trial database systems.

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

• Effective oral and written communication skills.

• Sound judgment and decision-making capabilities.

• Ability to accurately follow project work instructions.

• Strong negotiation skills.

• Ability to manage risk and perform risk escalation appropriately.

• Occasional travel and drives to site locations may be necessary.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.