Clinical Research Coordinator

Description Specialized research professional, responsible for the overall design, conduct, and management of the clinical trial; supports, facilitates and coordinates the daily clinical trial activities and administration of the compliance, financial, personnel and other related aspects of the clinical study. Key Responsibilities Coordinates with Principal Investigator, department, and administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures. Collaborates with institution to respond to any audit findings and implement approved recommendations. Perform study feasibility assessments as requested. Prepare IRB and any other regulatory submission documents as required by the protocol. Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials. Provide adequate communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria. Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards. General Knowledge/Competencies Ability to develop and deliver presentations. Knowledge of federal and state regulations & GCP guidelines (interpret and apply GCP) Ability to develop and / or implement clinical research monitoring plans and standard operating procedures. Ability to establish data collection and management guidelines Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards. Ability to work effectively within fast-paced working environments. Requirements Education/Skills: Bachelor’s degree in Health or Life Science (Medicine, Biotechnology, Chemistry). 3 year work experience in Clinical Research. Strong relationship with research stakeholders. Excellent communication, presentation, and interpersonal skills. Advanced English written and conversational skills. Knowledge of Good Clinical Practices Guidelines and international research guidelines, including ICH-E6. Knowledge of regulatory procedures with COFEPRIS (submission of adverse events, regulatory requirements for initial submissions). Desirable: Graduate or post-graduate degree in Life Sciences. Graduate or post-graduate degree in Business Administration, Finance, other. Management of Research Site or Research Operations, national or international. Proven clinical trial monitoring experience (Phase II to IV). PLEASE ADD YOUR RESUME WHEN APPLY. Thank you

Location: Monterrey, MX

Posted Date: 6/20/2025