Clinical Trial Coordinator I

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

📋 Description

• Provide both administrative and technical assistance to the Project Team.

• Facilitate audit readiness through regular file reviews in accordance with SOPs and departmental guidelines.

• Offer administrative support for site activation and assist in the creation of site activation critical paths.

• Create and evaluate site lists for feasibility activities while contributing local insights for site tiering.

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

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

• Ensure that assigned tasks are completed punctually, within budget, and meet quality standards.

• Provide assistance for Activate and eTMF systems, ensuring databases are kept up to date.

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

• Analyze and reconcile study metrics and findings reports effectively.

• Coordinate and disseminate Investigator Site File, pharmacy binder materials, and study supplies.

• Assist with translation materials and oversee translation quality control.

• Support meetings, regulatory document tracking, RBM activities, study documentation, training tracking, system access, and activity plans.

• Transmit documents to clients and centralized IRB/IEC efficiently.

• Maintain vendor trackers and assist with regulatory submissions.

• Collaborate with sites to acquire site-selection documents and aid in the regulatory compliance review process.

• Work in conjunction with internal departments to synchronize site start-up activities.

• Complete Site Interest Plans and gather the necessary investigator and site personnel documents when applicable.

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

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

• Collaborate with team members and clinical personnel on site issues, risks, deadlines, and follow-up plans.

• Serve as a local expert on site capacity and experience, identifying and cultivating new sites.

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

• Contribute to global feasibility processes and best practices.

• Train new personnel on processes and systems.

⛳️ Requirements

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

• Bachelor's degree preferred.

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

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

• Ability to work autonomously or collaboratively within a team.

• Strong organizational capabilities and meticulous attention to detail.

• Ability to manage multiple tasks effectively and efficiently.

• Ability to analyze project-specific data/systems for precision and efficiency.

• Strong focus on customer satisfaction.

• Flexibility to adjust workload priorities as needed.

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

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

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

• Ability to learn and master clinical trial database systems.

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

• Strong oral and written communication skills.

• Sound judgment and decision-making abilities.

• Ability to accurately follow project work instructions.

• Negotiation skills.

• Ability to manage risk and perform risk escalation appropriately.

• Occasional travel and driving to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.