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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Minimum qualifications
MBA/MSc/MA , Professional Certificate
How to apply
Use the link(s) below to apply on company website.
Compliance Officer, IHD Office
Consultant, Field Enumerator, LOSHAK, Population Health
https://www.myjobmag.co.ke/apply-now/1358578
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