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 Sciences Diploma (Medicine, Nursing, Pharmacy, Laboratory Sciences).
• Additional certification in Clinical Research or GCP required.
• A postgraduate degree in Public Health, Epidemiology, or Clinical Research is an asset.

Experience:

• 1 – 2 years of experience in clinical research or trial monitoring.
• Previous work with infectious diseases or hospital-based studies preferred.
• Experience with international NGOs or multi-partner projects is desirable.

Skills:

• Strong knowledge of GCP, clinical monitoring techniques, and regulatory compliance.
• Excellent command of medical and research terminology.
• Strong computer proficiency (MS Office Suite, EDC systems).
• Ability to draft clear and precise reports.
• Excellent interpersonal, communication, and organizational skills.
• Ability to work under pressure and manage priorities effectively.

Languages:

• Fluent in English (spoken and written).
• Knowledge of Hausa, Yoruba, Pidgin, or other local languages in Ondo and Bauchi States is an advantage.

Personal Qualities:

• Rigor, reliability, and integrity.
• Adaptability and flexibility in complex field settings.
• Respect for confidentiality and ethical sensitivity.
• Mobility and willingness to travel regularly to inclusion sites.
• Commitment to humanitarian and scientific values.