General Summary

Project Background:

The meningitis research Group aims to improve the diagnosis and treatment of various forms of meningitis in adults. Currently, 4 studies are running in Kampala and Mbarara:

COAST – an observational cohort study investigating etiologies and outcomes amongst adults presenting with meningitis.

HARVEST 2.0 - A Phase 2 Novel Antimicrobial Combination Therapy to Treat Tuberculous Meningitis

PLATFORM-CM - open-label randomized trial with single or potentially multiple interventional arms to compare the efficacy and safety of novel antifungal or adjunctive therapies to standard of care (SOC) controls of WHO first-line therapy.

ACACIA-

In order to strengthen support to these core areas of operation, the IDI-Meningitis research group seeks to recruit a Regulatory and Compliance Assistant who will provide support for regulatory, compliance, and quality management activities for clinical trials and observational studies within the Meningitis Research Group. The role ensures studies are conducted in accordance with national and international regulations, Good Clinical Practice (GCP), and institutional quality standards. The position reports to the Clinical Trial Manager/Trial Coordinator and works closely with study teams, monitors, and regulatory authorities.

Job Title: Regulatory affairs and Compliance Assistant

Projects: Meningitis Research Group

Classification: Full Time

Reporting To: Study Coordinator/Trial Manager

Duty Station: Kampala, Uganda

Key Responsibilities

Prepare, submit, and track regulatory submissions, approvals, renewals, protocol amendments, and continuing reviews, and follow up on outstanding regulatory-related actions for both international and local Research Ethics Committees (RECs/IRBs), sponsors, and regulatory authorities (UNCST, NDA) in coordination with the Clinical Trial Manager or study coordinator, and PIs.

Assist in the creation, maintenance, review, and updating of study regulatory binders (physical and/or electronic) across meningitis studies in line with GCP, sponsor requirements, institutional policies, and guidance from monitors and trial managers.

Support study teams in the development, review, and implementation of study-specific informed consent procedures and Standard Operating Procedures (SOPs), including those tailored to acute meningitis studies and vulnerable populations, where applicable.

Assist in the preparation, tracking, and submission of Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reports to RECs, sponsors, and regulatory authorities in coordination with the study medical officers, trial Coordinator/Trial Manager, and PI’s.

Provide administrative and logistical support during external monitoring visits, audits, and inspections related to meningitis clinical trials.

Support the review, tracking, and filing of signed Informed Consent Forms (ICFs), ensuring accurate and confidential consent tracking logs.

Assist in tracking and filing of staff Human Subjects Protection (HSP) and GCP training certificates, professional licenses, delegation logs, and study-specific training logs.

Liaise with study teams to follow up on action items arising from monitoring visits to ensure resolution.

Perform any other regulatory and compliance-related duties as assigned by the Trial Manager/Trial Coordinator.

Academic Qualifications

• Bachelor’s degree in Biomedical Sciences, Public Health, Social Sciences, or related field

Person Specification

Qualification and Experience

Bachelor’s degree in Biomedical Sciences, Public Health, Social Sciences, or related field.

1 year of experience in clinical research, research administration, regulatory support, or compliance (internships or attachments acceptable).

Basic knowledge of Good Clinical Practice (GCP) and Human Subjects Protection (HSP), or willingness to complete training upon appointment.

Understanding of regulatory requirements for clinical trials in Uganda (RECs/IRBs, UNCST, NDA).

Key Competencies and Skills

Organizational skills with strong attention to detail and accuracy.

Ability to track and maintain regulatory and quality documents.

Basic written and verbal communication skills for liaison with study teams and supervisors.

Computer literacy, including Microsoft Word, Excel, and email; familiarity with regulatory tracking systems is a plus.

Ability to manage multiple tasks and meet deadlines under supervision.

Ability to maintain confidentiality and handle sensitive data responsibly.

• Prepare, submit, and track regulatory submissions, approvals, renewals, protocol amendments, and continuing reviews, and follow up on outstanding regulatory-related actions for both international and local Research Ethics Committees (RECs/IRBs), sponsors, and regulatory authorities (UNCST, NDA) in coordination with the Clinical Trial Manager or study coordinator, and PIs.
• Assist in the creation, maintenance, review, and updating of study regulatory binders (physical and/or electronic) across meningitis studies in line with GCP, sponsor requirements, institutional policies, and guidance from monitors and trial managers.
• Support study teams in the development, review, and implementation of study-specific informed consent procedures and Standard Operating Procedures (SOPs), including those tailored to acute meningitis studies and vulnerable populations, where applicable.
• Assist in the preparation, tracking, and submission of Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reports to RECs, sponsors, and regulatory authorities in coordination with the study medical officers, trial Coordinator/Trial Manager, and PI’s.
• Provide administrative and logistical support during external monitoring visits, audits, and inspections related to meningitis clinical trials.
• Support the review, tracking, and filing of signed Informed Consent Forms (ICFs), ensuring accurate and confidential consent tracking logs.
• Assist in tracking and filing of staff Human Subjects Protection (HSP) and GCP training certificates, professional licenses, delegation logs, and study-specific training logs.
• Liaise with study teams to follow up on action items arising from monitoring visits to ensure resolution.
• Perform any other regulatory and compliance-related duties as assigned by the Trial Manager/Trial Coordinator.

• Organizational skills with strong attention to detail and accuracy.
• Ability to track and maintain regulatory and quality documents.
• Basic written and verbal communication skills for liaison with study teams and supervisors.
• Computer literacy, including Microsoft Word, Excel, and email; familiarity with regulatory tracking systems is a plus.
• Ability to manage multiple tasks and meet deadlines under supervision.
• Ability to maintain confidentiality and handle sensitive data responsibly.

• Bachelor’s degree in Biomedical Sciences, Public Health, Social Sciences, or related field.
• 1 year of experience in clinical research, research administration, regulatory support, or compliance (internships or attachments acceptable).
• Basic knowledge of Good Clinical Practice (GCP) and Human Subjects Protection (HSP), or willingness to complete training upon appointment.
• Understanding of regulatory requirements for clinical trials in Uganda (RECs/IRBs, UNCST, NDA).