Clinical Research Assistant

Context ALIMA is implementing the INTEGRATE clinical trial in Nigeria, a multinational research initiative focused on improving treatment outcomes for Lassa Fever. The project combines clinical care with operational research to strengthen evidence-based medical responses and local research capacity. Mission & Objectives The Clinical Research Assistant (CRA) supports the monitoring and quality assurance of the INTEGRATE clinical trial in Nigeria. He/she ensures that study activities comply with Good Clinical Practice (GCP), the research protocol, and ethical and regulatory standards. The CRA will regularly visit study sites to monitor progress, verify data accuracy, and assist with problem-solving related to trial operations. Main Responsibilities Clinical Monitoring and Quality Assurance: Monitor compliance with Good Clinical Practice (ICH E6 R2) and study SOPs at each site. Verify the accuracy and consistency of data entries with source documents. Ensure timely reporting of adverse and serious adverse events (SAEs). Support site staff in resolving data queries and protocol deviations. Prepare and submit detailed monitoring visit reports to the INTEGRATE coordination team. Verify that trial documentation (regulatory binders, consent forms, logs) are current and compliant. Participate in end-of-study closure activities. Coordination and Communication: Act as the liaison between site teams, ALIMA coordination, and international monitors. Participate in weekly coordination meetings and contribute to quality improvement. Communicate any field-level challenges, deviations, or technical needs promptly. Support training and capacity-building activities for local site staff on GCP and study procedures. Compliance, Ethics, and Data Integrity: Ensure strict confidentiality of patient and trial data. Monitor adherence to national ethics committee and regulatory authority requirements. Uphold ALIMA’s principles of data protection, transparency, and accountability. Ensure all trial activities adhere to ALIMA’s policies on PSEA, safety, and ethical conduct. Infection Prevention and Control (IPC): Comply at all times with Lassa fever IPC protocols when in wards and laboratories. Enforce adherence to biosafety and PPE procedures during field visits. Report any IPC breaches or exposure incidents to the Safety Focal Point. Contribution to Research Development: Assist in documentation and analysis of trial progress. Contribute to local capacity building by mentoring junior research staff. Support the dissemination of research outcomes at local and national levels, under supervision. Professional Conduct: Maintain professional behavior in accordance with ALIMA’s values and ethics. Show initiative and autonomy in problem-solving while maintaining team spirit. Participate actively in team meetings, briefings, and training sessions. Promote an environment of respect, collaboration, and continuous learning. Experience And Skills Education: Medical, Paramedical, or Life