Site Study Coordinator - Nurse at Health Initiatives for Safety and Stability in Africa (HIFASS)

Overview

• The African Cohort Study is a study to assess the impact of clinical practices, biological factors and socio-behavioural issues on HIV infection and disease progression in an African context in sites at DHQ/MC Abuja and 68NARH Yaba, Lagos.

Basic Function

• To participate in protocol development as may be applicable; prepare documents for submission to the IRBs and other regulatory authorities; oversee study execution in the target population including the youth cohort; and ensure adherence to protocol by all and compliance with applicable laws.
• Regulations, policies and procedural requirements.
• Perform nursing duties in the clinic.

Essential Job Functions, Duties, and Responsibilities

• Explain the purpose and nature of the study to new study participants.
• Answer participants’ questions and concerns.
• Enroll and consent potential study participants.
• Collect participants’ sample, including but not limited to phlebotomy as backup to study staff as needed.
• Work with the laboratory to ensure result collection is completed according to standard operating procedures.
• Provide safety and protection to all participants while collecting and managing data obtained from the participants from the study.
• Assess vital signs of the participants.
• Perform cervical cancer screening of female participants using the speculum, visual inspection with acetic acid (VIA), HPV specimen collection as backup to study staff as needed.
• Triage participants at the clinic as needed.
• Oversee and coordinate recruitment, care, and treatment of research subjects and liaise with other internal departments and external collaborators.
• Oversee study-related activities such as chart preparation, protocol trainings, SOP development, preparation of relevant study forms and labels.
• Audit clinical study records: compare case report forms with source documents; review other study relevant files.
• Oversee planning, scheduling and carrying out of procedures to provide adequate care and treatment of research subjects. Contact volunteers and schedule follow-up appointments as appropriate.
• Enter data for specific visit on CRF; audit records for accuracy, ensure completed CRFs in a timely manner, and support all QA/QC processes.
• Resolve data and record discrepancies identified during in-house reviews.
• Schedule monitoring visits as necessary. Coordinate staff in preparation for monitoring visits.
• Perform periodic review of the regulatory binder to ensure accuracy and completeness.
• Demonstrate knowledge and understanding of human research policies (specifically, subjects of minor age), regulations, standards, and procedures according to GCP guidelines (must pass all relevant CITI modules).
• Prepare protocol-required reports such as Adverse Events (AEs), Continuing Review Reports (CRRs) and other reports as needed. In addition, monitor deadlines of these reports/events.
• Supervise personnel to include, training, work allocation, and problem resolution as may be applicable.
• Track enrollment and loss to follow up statistics and provide weekly summaries of items within the schedule of events (SOE).
• Perform other job-related duties as may be assigned.

Job Specification

Minimum Education / Training Requirement:

• Bachelor’s Degree (or Diploma) in Nursing from an accredited institution.
• Successful completion of the CITI Group 3 Modules with at least 80% score in each module and Master’s Degree in Public Health will be an added advantage.

Prior Work Experience:

• 3 - 5 years related work experience including 2 years in supervisory position.
• Experience in clinical research including informed consent procedures.
• Hands-on experience and responsibility in research study implementation.
• Required Licenses, Certification or Registration: Registered by Nursing and Midwifery Council of Nigeria (with current practicing license).

Knowledge and skills:

• A good understanding of principles of research ethics and GCP
• Working understanding of IRB and protocol implementation, monitoring, and reporting requirements.
• Excellent interpersonal and organizational skills
• Effective communication and counselling skills
• Ability to work on own initiative, to prioritize and organize competing workloads and yet retain sufficient flexibility to respond to new circumstances rapidly
• Attention to detail and systematic approach to the work.
• Leadership skills and team-building abilities
• Training in research ethics, including Human Subjects Protection
• Protocol specific trainings
• Knowledge of scientific writing and presentation skills is desired
• Familiarity and experience working with computer programs such as Microsoft office suite and adobe acrobat. Experience with REDCap software will be an added advantage.