Administrative and Regulatory Affairs Officer at Kenya Medical Research - KEMRI

Key Responsibilities:

• Manage and optimize the Site Manager’s calendar, meeting schedule, and daily priorities, ensuring protected time for high-value operational, supervisory, and strategic tasks while proactively flagging scheduling conflicts and approaching deadlines
• Maintain structured task tracking systems and dashboards across all active deliverables, action points, and deadlines; develop automated reminders and accountability tools using Excel, Asana, Trello, or equivalent platforms
• Prepare meeting agendas, compile background documents, take minutes, and ensure follow-up for internal coordination meetings, team meetings, advisory board meetings, stakeholder engagements, and site visits
• Coordinate logistics for all meetings, delegation visits, and all-team gatherings, including travel planning, expense reporting, document preparation, and forward-looking scheduling
• Track all regulatory submissions and approvals for IRBs, Ethics Committees, PPB, NACOSTI, and KEMRI ERC; monitor timelines, expiries, renewals, protocol amendments, continuing review submissions, re-consents, and safety reports across studies
• Maintain a live regulatory and operational tracker/dashboard with status updates for each study and regulatory body, ensuring timely circulation of updates, meeting outcomes, and institutional communications across teams
• Support preparation and compilation of regulatory submission packages, operational briefs, performance summaries, and periodic reports for internal and external stakeholders
• Improve and oversee documentation flow, version control, filing systems, and SOP adherence across departments, identifying gaps or bottlenecks and proposing solutions to streamline processes
• Proactively flag risks, potential delays, or pending actions to the Site Manager and relevant study teams, issuing timely reminders and follow-ups to department heads, study coordinators, and administrative staff
• Identify process inefficiencies, propose and implement solutions, and ensure tasks move from planning to completion, supporting accountability and operational excellence across the site

Vacancy Requirements:

• Bachelor’s Degree in Public Health, Business Administration, Project Management, Health Systems Management, or related field    Mandatory
• Minimum 1–2 years’ experience in: Clinical research administration, Project coordination, or Executive/operations support in a fast-paced environment    Mandatory
• Experience working in clinical trials or research environments is an added advantage    Added Advantage
• Familiarity with IRB/EC and regulatory submission processes    Mandatory
• Knowledge of using project management tools (e    Mandatory
• Strong stakeholder engagement and follow-up skills    Mandatory
• Strategic thinking ability beyond pure administration    Mandatory
• Strong organizational and prioritization skills    Mandatory
• High attention to detail, especially in regulatory tracking    Mandatory
• Ability to manage multiple parallel workstreams    Mandatory
• Proactive problem-solving mindset    Mandatory
• Strong written and verbal communication skills    Mandatory