Job Description
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.