Vacancies at Aga Khan University Hospital

Job Summary

The position will provide independent oversight of ethics and regulatory requirements across IHD research programmes while supporting investigators in maintaining compliance throughout the lifecycle of approved studies. The Officer will also provide continuous support for research governance processes and contribute to continuous quality improvement in research conduct. The position is advisory in design and does not replace the roles of the Principal Investigators or the Institutional Scientific, Ethics and Regulatory Committee (ISERC).

The Officer shall provide compliance oversight across the IHD research programme and studies involving human participants. Roles and responsibilities shall include ethics and regulatory support from protocol approval through to study close-out. Oversight intensity will be determined using a risk-based approach, and will be proportionate to study design, study risk, study complexities and regulatory history.  During oversight, the Officer shall identify ethics and regulatory opportunities for improvement and support compliance, rather than act as an enforcement or disciplinary authority. 

Responsibilities

Regulatory Oversight:

• Monitor and support compliance with approvals issued by institutional, national and international Ethics Review Committees.
• Maintain a central regulatory tracking system for approved studies and research programmes at IHD.
• Review completeness and accuracy of ethics and regulatory files for approved studies and research programmes at IHD.
• Review and verify that requisite approvals are obtained for approved IHD studies and research programme before commencement of study activities.
• Monitor and flag approaching expiry dates for ethics approvals, permits and regulatory authorizations for approved studies and research programme at IHD.
• Monitor and verify implementation of approved protocols and amendments in line with ethics and regulatory committee requirements and conditions for approval.

Research Compliance:

• Develop, review and implement plans for routine annual compliance monitoring activities
• Review and verify adherence to approved protocols and Standard Operating Procedures.
• Review, identify and document protocol deviations and protocol violations.
• Support with monitoring for implementation of any corrective and preventative actions.
• Develop routine written compliance monitoring reports.

 Informed Consent:

• Periodically review and advise on the use of approved informed consent forms.
• Periodically observe and advise whether participants receive adequate information during. consenting, and that consent is appropriately documented.
• Review and advice whether participant privacy and confidentiality is maintained.

 Biological Samples Governance:

• Review participant consenting relating to sample collection, storage and use.
• Review and advise on sample collection, sample labelling, sample processing and sample storage tools, processes and procedures.
• Review sample inventory management, sample transportation, sample shipment, sample reception and long-term storage processes and procedures.

Training and Capacity Building:

• Identify ethics and regulatory compliance training needs.
• Organize and facilitate periodic ethics and regulatory compliance training sessions
• Provide training and regulatory updates to Investigators.
• Support onboarding and training of new research staff on ethics and regulatory compliance.
• Promote ethics, regulatory, and Good Clinical Practice principles.

Research Documentation, Data Protection and Reporting:

• Review and advise on essential documents including the Investigator site files, staff training logs, delegation logs, screening logs, enrolment logs, regulatory correspondence, protocol version control and data archiving.
• Review and support compliance relating to participant confidentiality, secure data storage, access control, data anonymization, data sharing, and material transfer agreements.
• Review and support readiness for research audits, regulatory inspections, and implementation of audit recommendations.
• Prepare periodic reports summarizing compliance monitoring activities, findings, corrective actions, institutional compliance and recommendations for continuous improvement.

Requirements

• Master’s degree in public health, Clinical research, Epidemiology, Health Sciences, Pharmacy, Nursing, Medicine, or a related discipline
• Minimum five years' experience in research ethics, regulation, governance, clinical research management, quality assurance or regulatory affairs
• Demonstrated knowledge of research ethics, regulatory and governance frameworks.
• Certification in Good Clinical Practice (ICH-GCP).

Relevant Experience

• Experience supporting institutional ethics review committees, research audits or research inspections is an added advantage
• High integrity standards, ethical standards and ability to manage confidential information
• Excellent analytical skills, organizational skills and attention to detail
• Strong written communication skills, diplomacy skills and professional judgement skills
• Ability to work independently and/or with minimal supervision

Personal Characteristics & Behaviours

• Excellent interpersonal skills and the ability to build and maintain harmonious working relationships with diverse stakeholders.
• Professionalism, tact, and resilience when working under pressure or when managing challenging situations.
• A collaborative and respectful approach that fosters teamwork and advances a positive working environment.

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Job Summary.

The purpose of this role is to support data collection, i.e.  conducting household interviews and deploying actigraphy for the LOSHAK study in the following counties Kakamega, Kirinyaga, Kisumu, Kitui, Mombasa, Nairobi, Nakuru & Wajir.. 

Terms of Reference

Specific Tasks

• Participate fully in enumerator training, household mapping and listing, pilot testing, and all preparatory activities, and successfully complete the certification process.
• Identify, locate, and visit assigned households and respondents according to the approved sampling procedures.
• Build rapport with sampled households and participants.
• Introduce the study, explain its objectives, and obtain informed consent from respondents before commencing interviews.
• Administer study questionnaires and other approved data collection tools using the designated Computer-Assisted Personal Interviewing (CAPI) application.
• Conduct interviews in a professional, respectful, and culturally appropriate manner while maintaining confidentiality.
• Collect complete, accurate, and timely data in accordance with the study protocol and field procedures while ensuring data integrity is maintained.
• Prepare and submit daily field progress reports and other required documentation.
• Attend daily briefing and debriefing meetings and implement corrective actions as advised.
• Report any operational, technical, ethical, security, or data quality issues encountered during fieldwork and ensure documentation.
• Maintain a log and safeguard all project equipment, materials, and documents issued for fieldwork and frequently updating the Field Supervisor of their status.
• Comply with all study protocols, organizational policies, and fieldwork procedures.
• Perform any other field-related duties assigned by the field supervisor that are relevant to the successful implementation of the study.
• Administer the multi-module LOSHAK Core and HCAP Surveys (covering demographics, healthcare utilization, household economics, and family caregiving dynamics).
• Conduct complex cognitive and neuropsychological assessment batteries (e.g., the 21-item Swahili Mental State Examination, 10-word recall, and animal naming modules) with all participants, maintaining high patience and testing fidelity.
• Identify instances requiring proxy informants when selected respondents experience significant cognitive or physical impairments, following standardized study rules.
• Perform precise clinical, physical, and anthropometric measurements including blood pressure readings, hand-grip strength tests (using dynamometers), height, weight, waist, and hip circumferences.
• Coordinate the deployment and retrieval of wearable physical activity trackers given to select participants as well as reporting any malfunctioning of devices for timely resolution
• Verify that all CAPI data entries are accurate, comprehensive, logical, and structurally consistent before field submission.
• Synchronize data daily with the central institutional secure server to allow real-time data monitoring and quality sweeps by the data management team.
• Maintain accurate tracking logs of all field visits, callbacks (in cases where participants were absent), and refusals and communicate this to supervisors.    
• Resolve and/or provide clarity on all data quality issues that have been flagged for review by the DQA teams.

Requirements

• Possess at least a Diploma in Statistics, Public Health, Community Health, Social Sciences, Demography, Epidemiology, Computer Science or a related field.
• Have previous experience conducting household, community-based, or population-based surveys.
• Previous experience in national surveys led by KNBS
• Have experience using tablets, smartphones, or electronic data collection systems (CAPI) or any web-based data capture platform (CAWI).    
• Be familiar with handling basic clinical instruments (digital Blood Pressure machines, anthropometry devices, dynamometers).
• Be able to work independently under minimal supervision and as part of a team.
• Have fluency in English, Kiswahili, and the local language(s) spoken within the assigned study area.