Central Monitor II

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

📋 Description

• Conduct remote patient data review tasks for Phase I-IV clinical research and/or non-interventional studies.

• Evaluate adherence to protocols, ICH-GCP guidelines, and relevant local and federal regulatory standards.

• Safeguard patient safety and data integrity by utilizing various technologies.

• Examine protocols, critical data, process risks, safety risks, and potential data integrity issues.

• Analyze patient data listings and visualizations to verify eligibility and detect protocol deviations, patient safety issues, data integrity concerns, and any inaccuracies or missing information.

• Review factors impacting patient safety and clinical data integrity at investigator and physician sites.

• Communicate and escalate significant issues to the project team and formulate action plans with assistance.

• Record observations and formulate queries, protocol deviations, or action items in the appropriate systems.

• Confirm investigational product dispensing and administration, laboratory procedures, and ensure current and complete eTMF data.

• Track, report, and complete required project documentation to confirm activity completion.

• Oversee patient- and site-level activities to achieve project goals, deliverables, and timelines.

• Adjust to shifting priorities with guidance from the Lead CRA/LCMDA.

• Prepare for and participate in investigator and sponsor meetings.

• Engage in project staff meetings and clinical training sessions.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or a comparable mix of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH E6 (R2) Guidelines and/or other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Expertise in MS Excel, including sorting, filtering, calculating, and pivoting functions.

• Competence with Analytical Data Visualization Tools, including modifying visualizations and selecting data subsets.

• Exceptional verbal and written communication abilities.

• Capacity to inform, influence, and communicate effectively across various functions.

• Strong analytical capabilities.

• Developing expertise in therapeutic areas.

• Less than 10% travel, restricted to training sessions and investigator meetings.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when appropriate.