Location: Abuja, Nigeria (with frequent travel to Owo, Irrua, Bauchi, and other sites)
Reports to: Research Coordinator - Nigeria / INTEGRATE Coordination Team
Contract Duration: 6 months
Level: 09
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
At least 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.
Conditions
Contract type: Local Nigerian employment contract (6 months).
Salary level: According to ALIMA's national salary scale (Level 09).
Duty station: Abuja, with frequent travel to trial sites (Owo, Irrua, Bauchi).
Benefits: Health coverage, field per diem, Annual Leave, professional training in GCP and clinical monitoring.