3
Administrative And Regulatory Affairs Officer
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:
| # | Description. | Requirement Type |
|---|---|---|
| 1 | Bachelor’s Degree in Public Health, Business Administration, Project Management, Health Systems Management, or related field | Mandatory |
| 2 | Minimum 1–2 years’ experience in: Clinical research administration, Project coordination, or Executive/operations support in a fast-paced environment | Mandatory |
| 3 | Experience working in clinical trials or research environments is an added advantage | Added Advantage |
| 4 | Familiarity with IRB/EC and regulatory submission processes | Mandatory |
| 5 | Knowledge of using project management tools (e | Mandatory |
| 6 | Strong stakeholder engagement and follow-up skills | Mandatory |
| 7 | Strategic thinking ability beyond pure administration | Mandatory |
| 8 | Strong organizational and prioritization skills | Mandatory |
| 9 | High attention to detail, especially in regulatory tracking | Mandatory |
| 10 | Ability to manage multiple parallel workstreams | Mandatory |
| 11 | Proactive problem-solving mindset | Mandatory |
| 12 | Strong written and verbal communication skills | Mandatory |
