Institute Overview

• Ifakara Health Institute (IHI) is a leading research organization in Africa with a strong track record in developing, testing and validating innovations for health. Driven by a core strategic mandate for research, training and services, the Institute’s work now spans a wide spectrum, covering biomedical and ecological sciences, intervention studies, health-systems research, service delivery and policy translation.Position Summary
• Ifakara Health Institute is seeking a qualified Clinical Research Coordinator who will be stationed at Bagamoyo Office, reporting to the Head of Facility. The Clinical Research Coordinator, will be responsible for overseeing clinical trials or studies to test the effectiveness of biotechnology. The other duties includes sorting through applications and choosing qualified candidates, monitoring the health of each participant throughout the trial and compiling a report to summarize the success or failure of a particular drug, technology or medical procedure.

Responsibility:

• Operates the BCTF staffing-control, training, competence, controlled procedure and embedded-QC systems.
• Functionally supervises and supports trial-specific Clinical Trial Coordinators in applying BCTF systems, documentation and process requirements.
• Coordinates deviations, root-cause analysis, CAPA, change control and implementation of approved improvements.
• Serves as the primary operational support to the Head of BCTF for facility-wide and trial-specific audits, inspections and oversight visits.
• Coordinates readiness, documentation, responsible personnel, responses and follow-up actions.
• Coordinates BCTF interfaces with RQA and relevant IHI technical and administrative departments.
• Tracks agreed actions and escalated unresolved staffing, training, process, documentation or compliance deficiencies to the Head of BCTF.
• Verify with trial specific coordinators on
  o Each trial’s staffing, training, delegation, controlled-document, process-QC and institutional-support requirements.
  o Required personnel, procedures, records and quality controls are ready before activation.
  o Coordinates trial-specific Clinical Trial Coordinators and relevant BCTF and IHI technical leads during trial set-up, conduct, close-out and inspection readiness.
  o Reassesses readiness following material protocol, staffing, process, system or risk changes.

Skill :

• Strong knowledge of GCP, quality-management systems and clinical-trial operations.
• Competence in staffing control, training management and competence assessment.
• Proficiency in controlled document and procedure management.
• Competence in process QC, deviations, root-cause analysis, CAPA and change control.
• Strong audit, inspection and oversight-visit readiness skills.
• Ability to coordinate trial teams and institutional support departments.
• Ability to monitor compliance, track actions and escalate unresolved risks.
• Strong organizational, documentation and records-management skills.
• High attention to detail, independence, accountability and problem-solving ability.

Qualification Required:

• Relevant degree or professional qualification in health sciences, clinical research associate, clinical medicine, biomedical sciences, preferable with certificate as CRA or a related field.
• Current GCP training.
• Substantial clinical-trial coordination or clinical-research management experience.
• Demonstrated competence in staffing controls, training and competence systems, SOP lifecycle management, document governance and embedded QC.
• Demonstrated competence in deviations, root-cause analysis, CAPA and change control.

Experience :

• Experienced in supervising or supporting Clinical Trial Coordinators.
• Experienced in coordinating multidisciplinary institutional departments and technical units supporting clinical research.
• Experienced in coordinating readiness for sponsor, regulatory, ethics and internal audits, inspections or oversight visits.

Preferred Language Skill :

• Strong communication (Swahili and English) and stakeholder-management skills.

• Operates the BCTF staffing-control, training, competence, controlled procedure and embedded-QC systems.
• Functionally supervises and supports trial-specific Clinical Trial Coordinators in applying BCTF systems, documentation and process requirements.
• Coordinates deviations, root-cause analysis, CAPA, change control and implementation of approved improvements.
• Serves as the primary operational support to the Head of BCTF for facility-wide and trial-specific audits, inspections and oversight visits.
• Coordinates readiness, documentation, responsible personnel, responses and follow-up actions.
• Coordinates BCTF interfaces with RQA and relevant IHI technical and administrative departments.
• Tracks agreed actions and escalated unresolved staffing, training, process, documentation or compliance deficiencies to the Head of BCTF.
• Verify with trial specific coordinators on
• o Each trial’s staffing, training, delegation, controlled-document, process-QC and institutional-support requirements.
• o Required personnel, procedures, records and quality controls are ready before activation.
• o Coordinates trial-specific Clinical Trial Coordinators and relevant BCTF and IHI technical leads during trial set-up, conduct, close-out and inspection readiness.
• o Reassesses readiness following material protocol, staffing, process, system or risk changes.

• Strong knowledge of GCP, quality-management systems and clinical-trial operations.
• Competence in staffing control, training management and competence assessment.
• Proficiency in controlled document and procedure management.
• Competence in process QC, deviations, root-cause analysis, CAPA and change control.
• Strong audit, inspection and oversight-visit readiness skills.
• Ability to coordinate trial teams and institutional support departments.
• Ability to monitor compliance, track actions and escalate unresolved risks.
• Strong organizational, documentation and records-management skills.
• High attention to detail, independence, accountability and problem-solving ability.

• Relevant degree or professional qualification in health sciences, clinical research associate, clinical medicine, biomedical sciences, preferable with certificate as CRA or a related field.
• Current GCP training.
• Substantial clinical-trial coordination or clinical-research management experience.
• Demonstrated competence in staffing controls, training and competence systems, SOP lifecycle management, document governance and embedded QC.
• Demonstrated competence in deviations, root-cause analysis, CAPA and change control.