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

Reports To: Principal Investigator
Work Hours: full-time 40 hours/week

Basic Functions

• To participate in protocol development as may be applicable; prepare documents for submission to the IRBs and other regulatory authorities 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 participants joining the study
• Answer participants’ questions and concerns.
• S/He will 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 done 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, and ensure completed CRFs in a timely manner.
• 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 completeness.
• Prepare protocol-required reports such as AEs. Continuing Review Reports (CRRs) and other reports as needed. Monitor deadlines.
• Supervision of personnel to include, training, work allocation, and problem resolution as may be applicable.
• Perform other job-related duties as may be assigned.
• Track enrollment and lost to follow up statistics and provide weekly summaries of items within the schedule of events (SOE).

Job Specification
Minimum Education/Training Requirements:

• Bachelor's Degree (or Diploma) in Nursing from an accredited institution.
• Must have successfully completed the CITI Group 3 Modules with at least 80% score in each module. Master’s degree in Public Health will be an added advantage.

Prior Work Experience:

• Minimum of 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
• 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 his/her 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.

Other Specifications:

• Candidates must be resident or ready to relocate to Lagos. Interviews will be conducted in Abuja. Candidates invited are responsible for their transportation and accommodation.