Central Monitor II - Remote Mexico

About the role

Syneos Health is hiring a Central Monitor II (CM II) to work remotely in Mexico. The role performs remote patient data review for Phase I-IV clinical research and/or non-interventional studies, assessing compliance with the protocol, ICH-GCP and applicable local and federal regulatory requirements, while ensuring patient safety and data integrity.

Key responsibilities

• Review protocols, critical data, processes, safety and data integrity risks related to protocol execution.
• Review patient data listings and visualizations on dashboards and reports to confirm eligibility, spot protocol deviations, safety concerns, data integrity issues and missing or inaccurate data.
• Assess factors affecting patient safety and data integrity at investigator sites, such as protocol deviations and pharmacovigilance issues.
• Escalate serious issues immediately and develop action plans with guidance.
• Document observations, write queries, protocol deviations or action items, and track completion of activities per SOPs and the Monitoring Plan.
• Verify that investigational product was dispensed and administered, that laboratory and other procedures were performed, and that eTMF data is current and complete.
• Manage patient- and site-level activities within project scope, budget and timeline, adapting quickly to changing priorities under the oversight of the Lead CRA/LCMDA.
• Prepare for and attend investigator and sponsor meetings, project staff meetings and clinical training sessions.

Required profile

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience.
• Knowledge of ICH-GCP guidelines and/or other applicable regulatory requirements.
• Good computer skills and willingness to adopt new technologies.
• Excellent verbal and written communication skills and strong analytical skills.
• Less than 10% travel, limited to trainings and investigator meetings.

Required skills

• Mastery of MS Excel (sorting, filtering, calculating, pivoting).
• Proficiency with analytical data visualization tools.