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Full-time
Regulatory Affairs Assistant Job at Infectious Diseases Institute (IDI)
Infectious Diseases Institute (IDI)
Job Description
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.
Duties, Roles and 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.
Qualifications, Education and Competencies
See all details of the qualifications, competencies and education for this role under the "How to Apply" section below.
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