Background

KCA University (KCAU) is a private, non-profit institution, founded in July 1989 as Kenya College of Accountancy (KCA) by the Institute of Certified Public Accountants of Kenya (ICPAK) to improve the quality of accountancy and financial management training in the country. KCAU is located on Thika Road in Ruaraka, Nairobi, Kenya. 

Job Objective

The Administrative Assistant – ISERC Operations and Compliance will be responsible for providing administrative and operational support to the Institutional Scientific and Ethics Review Committee (ISERC) Secretariat to facilitate the efficient management of research ethics review and post-approval monitoring activities. The role supports compliance tracking, records management, and coordination of monitoring activities to ensure adherence to University policies and the National Commission for Science, Technology and Innovation (NACOSTI) requirements.

Duties and Responsibilities

• Monitor ongoing research projects to ensure compliance with approved protocols, university policies and national and international ethical guidelines.
• Coordinate post-approval oversight activities, including tracking ethical approval renewals, annual progress reports, protocol amendments, and study closure reports.
• Support and coordinate routine and for-cause monitoring visits and audits to assess adherence to approved procedures and protect research participants, under the guidance of relevant research oversight personnel.
• Support the documentation and coordination of protocol deviations, non-compliance cases, and participant complaints, and escalate these to the relevant personnel for review and appropriate corrective and preventive action.
• Monitor and support reporting of adverse events and unanticipated problems, ensuring timely communication to the Scientific and Ethics Review Committee and relevant regulatory bodies.
• Support the safeguarding of the rights, safety, dignity, and confidentiality of research participants by facilitating the proper documentation and implementation of informed consent and ethical requirements.
• Maintain comprehensive records and databases relating to compliance activities, monitoring reports, site visits, and regulatory documentation.
• Prepare administrative and periodic compliance reports, and support compiling information and documentation for management and the Scientific and Ethics Review Committee on research oversight and regulatory compliance.
• Support quality assurance and continuous improvement initiatives, including the development and review of Standard Operating Procedures (SOPs), accreditation processes, and institutional research governance systems.
• Support the ethical clearance process in report preparation, documentation, tracking of submissions, and other related activities.

Qualifications And Experience

• Bachelor’s Degree in Social Sciences, Health Sciences, Communication, Information Science or related disciplines from an accredited and recognised University.
• Training in Research Ethics and Responsible Conduct of Research.
• At least one (1) year of experience in research administration, ethics review, compliance monitoring, quality assurance, or research management in a University or a comparable Institution.
• Experience working with Institutional Scientific and Ethics Review Committees (ISERCs), Institutional Review Boards (IRBs), or research institutions will be an added advantage.
• Experience in conducting audits, inspections, or monitoring research projects is desirable.

Other Skills And Competencies

• Knowledge of NACOSTI guidelines and international ethical standards.
• Strong analytical and report-writing skills.
• Ability to conduct inspections, audits, and investigations objectively.
• Excellent communication and interpersonal skills.
• Proficiency in Microsoft Office applications and electronic records management systems.
• Ability to work independently and maintain confidentiality.
• High ethical standards, integrity, and attention to detail.
• Computer skills in relevant areas from a recognised Institution.

• Monitor ongoing research projects to ensure compliance with approved protocols, university policies and national and international ethical guidelines.
• Coordinate post-approval oversight activities, including tracking ethical approval renewals, annual progress reports, protocol amendments, and study closure reports.
• Support and coordinate routine and for-cause monitoring visits and audits to assess adherence to approved procedures and protect research participants, under the guidance of relevant research oversight personnel.
• Support the documentation and coordination of protocol deviations, non-compliance cases, and participant complaints, and escalate these to the relevant personnel for review and appropriate corrective and preventive action.
• Monitor and support reporting of adverse events and unanticipated problems, ensuring timely communication to the Scientific and Ethics Review Committee and relevant regulatory bodies.
• Support the safeguarding of the rights, safety, dignity, and confidentiality of research participants by facilitating the proper documentation and implementation of informed consent and ethical requirements.
• Maintain comprehensive records and databases relating to compliance activities, monitoring reports, site visits, and regulatory documentation.
• Prepare administrative and periodic compliance reports, and support compiling information and documentation for management and the Scientific and Ethics Review Committee on research oversight and regulatory compliance.
• Support quality assurance and continuous improvement initiatives, including the development and review of Standard Operating Procedures (SOPs), accreditation processes, and institutional research governance systems.
• Support the ethical clearance process in report preparation, documentation, tracking of submissions, and other related activities.

• Knowledge of NACOSTI guidelines and international ethical standards.
• Strong analytical and report-writing skills.
• Ability to conduct inspections, audits, and investigations objectively.
• Excellent communication and interpersonal skills.
• Proficiency in Microsoft Office applications and electronic records management systems.
• Ability to work independently and maintain confidentiality.
• High ethical standards, integrity, and attention to detail.
• Computer skills in relevant areas from a recognised Institution.

• Bachelor’s Degree in Social Sciences, Health Sciences, Communication, Information Science or related disciplines from an accredited and recognised University.
• Training in Research Ethics and Responsible Conduct of Research.
• At least one (1) year of experience in research administration, ethics review, compliance monitoring, quality assurance, or research management in a University or a comparable Institution.
• Experience working with Institutional Scientific and Ethics Review Committees (ISERCs), Institutional Review Boards (IRBs), or research institutions will be an added advantage.
• Experience in conducting audits, inspections, or monitoring research projects is desirable.