Senior Regulatory Compliance Specialist

Company information

Company

HST Careers

Division

FRESH

Females Rising through Education, Support and Health

Province

KwaZulu-Natal

Job Specification Information

Title

Senior Regulatory Compliance Specialist

Description

The Health Systems Trust (HST) is hiring a Senior Regulatory Compliance Specialist (SRCS), to support the work of Principal Investigators (PIs) from South Africa and the United States who hold a faculty position at the Ragon Institute of MGB, MIT and Harvard, USA. The successful candidate will work closely with the PIs to manage the regulatory requirement of their human subjects research conducted in Durban, KwaZulu-Natal, South Africa. Clinical studies are conducted 20 minutes south of Durban at the HST project site, FRESH, which is an established clinical research platform. Basic science investigations are conducted at laboratories at the University of KwaZulu-Natal, Nelson Mandela School of Medicine at the HIV Pathogenesis Programme (HPP) and the African Health Research Institute (AHRI). It is the role of the SRCS to ensure that all research activities are conducted in full compliance with regulatory requirements, ethical standards, Good Clinical Practice (GCP), sponsor guidelines, and institutional policies. The research includes clinical trials, clinical and socio-behavioural studies, and secondary use of biological specimens and data. The SRCS will report to the Ragon’s Regulatory Compliance Programme Director. This is a 12-month fixed-term contract position, renewable based on funding.

Key Responsibilities

Pre-Study • Ensure the PIs and selected research team members complete protocol review, preparation of essential regulatory documents including protocol informed consent forms (ICFs), and Case Report Forms (CRFs), as applicable. • Working with Principal Investigators/Study Co-ordinator (PIs/SC), oversee initial submissions to local Ethics Committee (EC), International Institutional Review Boards (IRBs) and where appropriate, National Regulatory authorities. • Support the PI to respond rapidly to regulatory queries, as needed. • For interventional studies, confirm with the PI whether there will be an integrated socio-behavioural research study and support parallel ethics/regulatory submission. • For clinical trials, assist PIs/SC with arranging Site Initiation Visit (SIV), mock run-through and study launch, for applicable studies, as needed. • Prepare, review, and submit start-up packet for members of the study team, including required documentation of training/delegation logs, curriculum vitae (CVs), Good Clinical Practice (GCP) certification, and where applicable, professional licensure (nursing, medical, pharmacy, etc), malpractice insurance and dispensing licenses. • Ensure early community engagement; protocol and ICFs to be reviewed by the HPP Community Advisory Board (CAB) and solicit input and obtain letter of support prior to submission of study documents to regulatory bodies. Study Implementation • Working with PIs/SC to oversee submission of protocol amendments, safety reports, annual progress reports, and study renewals. • Track approval timelines and ensure no study activity occurs without valid approval from all involved regulatory bodies. • Schedule regular communication with the local site PI, site research team, staff, core lab members from UKZN HIV Pathogenesis Programme (HPP), the Ragon Institute, and other Institutions as needed. • Participate in sponsor meetings and strategic planning discussions, including (but not limited to) developing the regulatory strategy for complex trials. • Support sponsor audits, regulatory inspections, and monitoring visits. • Support response to compliance gaps and implementation of Corrective and Preventive Actions (CAPA). • Work closely with PI/SC and site research team to ensure close monitoring of study participants for development of adverse events (AEs) and serious adverse events (SAEs), suspected/unexpected serious adverse reaction (SUSAR) and protocol deviations (PDs). • Ensure version control of Protocols, Informed Consent Forms, Investigator Brochures, Standard Operating Procedures (SOPs), and other essential documents. • Ensure PI is aware of all AE/SAE, SUSAR and PDs. • Ensure the site team has a system for rapid review of diagnostic lab results, and review/management with PIs/sub-Is. • Working with the appropriate PI, oversee submission of safety reports, adverse events, and ongoing reports to IRB/Sponsors within required institutional timelines. General Management • Work with the Ragon Regulatory team to establish appropriate standards for all relevant regulatory bodies including UKZN BREC, Mass General Brigham (MGB) IRB and where appropriate, the IRBs of collaborators allowing for the mutual acceptance of protocol conduct by different regulatory authorities. • Maintain regulatory submission calendars and ensure submissions adhere to reporting deadlines. • Develop and maintain document tracking systems and compliance dashboards. • Maintain and update the Investigator Site File (ISF) / Regulatory Binder in accordance with International Conference on Harmonization (ICH) and GCP. • Keep all documentation (e.g., Maintaining the Investigator Site File (ISF), Trial Master File (TMF), etc.) "inspection ready". • Ensure regulatory submissions within South Africa have the corresponding updates in the US and vice versa. • Archive study files according to regulatory retention requirements. • Ensure studies comply with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), South Africa Good Clinical Practice (SA GCP), national regulatory authority requirements, and international regulatory requirements. • Identify and comply with any safety reporting requirements that may be unique to a given sponsor/medical monitor or institution. • Assist PI/SC with development, review, and updating for each trial/study protocol: Standard operating procedures (SOPs), CRFs and Lab order forms. • Adherence to good laboratory practices (GLP) regarding sample collection, labelling, processing, handling and storage requirements are followed. • Ensure that Institutional Agreements are managed as required. • Ensure shipping permits, both export and import, are in place • Ensure logs/transfer of samples (courier) are maintained. • Ensure data sharing agreements are properly managed prior to any data exchange. Engagement with the PI and Study Team • Act as liaison between PI, research team, sponsors, CROs, ethics committees, and regulatory authorities. • Communicate regulatory updates and approval statuses to study teams. • Liaise with Data Monitor, Quality Control Officer (QCO) and Data Capturers to set up data management/transfer for each study. • Provide or arrange training on regulatory requirements and processes for delegated research staff. • Work with the QCO and data team to ensure CRFs are complete. • Ensure clinical team has undergone recent Basic Life Support (BLS) training or other human subject training requirements. • Identify any gaps in regulatory skills/knowledge amongst the study team and arrange for remediation/re-training. • Contribute to staff coaching internally; share expertise with the research team. Community Engagement and Dissemination of Results • Ensure the site reports new studies to civil society through the Provincial and District AIDS Counsel (DAC). • Ensure the PI/study team disseminates study results to the community at study conclusion (CAP, P/DAC, etc.).

Key Attributes

• Ability to manage multiple protocols simultaneously. • Excellent time management and organizational skills. • High attention to detail and accuracy • Ability to manage multiple studies and deadlines • Meticulous in documenting data, recordkeeping and ensuring accuracy Experience

Education Required

Matric

Qualification Required

• Grade 12 certificate • Bachelor’s degree in health sciences, pharmacy, nursing, life sciences, or related field

Experience Required

• 5+ years in clinical research setting / 2+ years of experience in regulatory affairs • GCP certification • Experience with research, including clinical trial, social behavioural research studies, and secondary use of specimens/data or bench science • Fluency in English is a must, and in isiZulu is an advantaged Experience • Experience with national regulatory authority and ethics committee submissions • Familiarity with ICH-GCP guidelines, local and international regulatory framework • Experience with submission(s) to South African Health Products Regulatory Authority (SAHPRA) • Strong knowledge of ICH-GCP, SAHPRA processes and South African regulatory requirements • Experience obtaining approval from Provincial Department of Health Research • Familiarity with United States regulatory regulations

Remuneration

A salary package commensurate with the successful candidate’s experience and qualifications and in line with HST’s Job Grading System will be offered.

Other Job Details

• Interested applicants must complete their application online at: https://careers.hst.org.za/ • Applicants are to ensure that the online applications are completed in full, and that comprehensive CV’s are uploaded with the online application in order to be considered. • Applicant’s CV must be saved with a filename reflecting their name and surname. • No applications sent via email will be considered for the job, as all applicants must submit their applications online at the provided link. PLEASE NOTE: • Personal information collected is processed lawfully in terms of the Protection of Personal Information Act (POPIA). • Shortlisted candidates will be requested to submit certified copies of all qualifications and identity documents. • Applications received after the closing date will not be considered. • Correspondence will be limited to shortlisted candidates. • All shortlisted candidates will be subjected to reference and credential checks. • If you have not been contacted within 30 days of the closing date of this advertisement, please accept that your application has been unsuccessful. • HST reserves the right to not fill this position. CLOSING DATE FOR APPLICATIONS: 04 June 2026 Health Systems Trust subscribes to diversity and inclusivity, which is informed by the Company’s Employment Equity Plan. Based on this, African males and people with disabilities who meet the job specifications (including but not limited to the required skills, knowledge and education), are encouraged to apply.