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 Medical Doctor Specialist (Physician) who will be stationed at Bagamoyo Office under SINCEP- Africa project reporting to the Project Leader. The position is responsible for implementation of ICH-GCP, local regulatory and ethical requirements on the provision of the clinical safety and emergency-readiness function through which BCTF ensures that appropriate personnel, equipment, medicines, monitoring systems, referral pathways and transfer arrangements are available for safe trial conduct. The unit translates trial-specific risks into operational requirements, verifies readiness before trial activation and dosing, and oversees emergency assessment, resuscitation, stabilization, referral and transfer capability across the facility.

Responsibility:

• Ensures that approved procedures for emergency assessment, resuscitation, stabilisation and hospital transfer are in place and operational.
• Ensures that referral-hospital, ambulance, out-of-hours medical and escalation arrangements are formally agreed, current and accessible to relevant personnel.
• Verifies that minimum requirements for clinical monitoring, medical cover and emergency readiness are applied across the facility.
• Reviews and approves emergency-trolley configuration, dosing-bed suitability, alarm coverage and emergency-access arrangements.
• Leads the emergency-scenario programme and ensures that attendance, findings, lessons and corrective actions are documented.
• Reviews clinical-readiness deficiencies, assigns corrective actions and escalates unresolved risks to the Head of Facility.
• Reviews each trial risk assessment to determine whether BCTF’s standing clinical and emergency capability is sufficient.
• Specifies additional monitoring, rescue treatment, specialist support, staffing, medical presence and trial-specific emergency arrangements required before activation.
• Ensures that referral pathways, transfer information, emergency equipment and clinical cover are appropriate to the protocol and investigational product risks.
• Verifies completion of required mitigations before recommending trial activation and dosing.
• Reassesses readiness where the protocol, safety information, participant population or risk profile changes.
• Ensures that the following activities are assigned by the PI to appropriately qualified, trained and competent personnel and documented in the study-specific delegation log;-
  • Medical-history and eligibility review;
  • Participant clinical assessment and monitoring;
  • Dosing-day and post-dose medical cover;
  • Participant-specific safety review;
  • Application of protocol stopping or escalation criteria; and
  • Protocol-specific emergency, referral and transfer duties.

Skill :

• Strong knowledge of resuscitation, stabilization, referral and hospital-transfer requirements.
• Competence in clinical-trial risk assessment and participant-safety oversight.
• Ability to assess protocol, investigational-product and population-specific risks.
• Advanced clinical judgement and emergency-response competence.
• Ability to define appropriate monitoring, staffing, medical-cover and emergency arrangements.
• Competence in evaluating emergency equipment, clinical monitoring and facility readiness.
• Ability to lead emergency simulations and corrective-action follow-up.
• Strong knowledge of GCP, delegation and PI oversight requirements.
• Ability to assess personnel qualifications, training and competence.
• Strong leadership, decision-making, escalation and multidisciplinary coordination skills.
• Clear written and verbal communication.
• High attention to detail, accountability and commitment to participant safety. Team worker, able to work in a multi culture environment, punctual and with high integrity.

Qualification Required:

• Medical Doctor Specialist (Physician) with current professional registration.
• Current GCP and recognised advanced life-support certification or approved equivalent.

Experience :

• Relevant clinical-trial and recent emergency-management experience.
• Competence in resuscitation, stabilisation, transfer, clinical risk assessment, emergency-cover planning and readiness verification procedures.

Preferred Language Skill :

• Clear written and verbal communication (English & Swahili).

• Ensures that approved procedures for emergency assessment, resuscitation, stabilisation and hospital transfer are in place and operational.
• Ensures that referral-hospital, ambulance, out-of-hours medical and escalation arrangements are formally agreed, current and accessible to relevant personnel.
• Verifies that minimum requirements for clinical monitoring, medical cover and emergency readiness are applied across the facility.
• Reviews and approves emergency-trolley configuration, dosing-bed suitability, alarm coverage and emergency-access arrangements.
• Leads the emergency-scenario programme and ensures that attendance, findings, lessons and corrective actions are documented.
• Reviews clinical-readiness deficiencies, assigns corrective actions and escalates unresolved risks to the Head of Facility.
• Reviews each trial risk assessment to determine whether BCTF’s standing clinical and emergency capability is sufficient.
• Specifies additional monitoring, rescue treatment, specialist support, staffing, medical presence and trial-specific emergency arrangements required before activation.
• Ensures that referral pathways, transfer information, emergency equipment and clinical cover are appropriate to the protocol and investigational product risks.
• Verifies completion of required mitigations before recommending trial activation and dosing.
• Reassesses readiness where the protocol, safety information, participant population or risk profile changes.
• Ensures that the following activities are assigned by the PI to appropriately qualified, trained and competent personnel and documented in the study-specific delegation log;-
  • Medical-history and eligibility review;
  • Participant clinical assessment and monitoring;
  • Dosing-day and post-dose medical cover;
  • Participant-specific safety review;
  • Application of protocol stopping or escalation criteria; and
  • Protocol-specific emergency, referral and transfer duties.

• Strong knowledge of resuscitation, stabilization, referral and hospital-transfer requirements.
• Competence in clinical-trial risk assessment and participant-safety oversight.
• Ability to assess protocol, investigational-product and population-specific risks.
• Advanced clinical judgement and emergency-response competence.
• Ability to define appropriate monitoring, staffing, medical-cover and emergency arrangements.
• Competence in evaluating emergency equipment, clinical monitoring and facility readiness.
• Ability to lead emergency simulations and corrective-action follow-up.
• Strong knowledge of GCP, delegation and PI oversight requirements.
• Ability to assess personnel qualifications, training and competence.
• Strong leadership, decision-making, escalation and multidisciplinary coordination skills.
• Clear written and verbal communication.
• High attention to detail, accountability and commitment to participant safety. Team worker, able to work in a multi culture environment, punctual and with high integrity.

• Medical Doctor Specialist (Physician) with current professional registration.
• Current GCP and recognised advanced life-support certification or approved equivalent.