Job Description

Introduction

The successful incumbent will join an International Foundation's Clinical Trials Unit in Durban

Duties & Responsibilities

Develop and maintain Standard Operating Procedures relevant to the portfolio. Coordinate regulatory obligations (initial submissions, amendments, re-certification, reports, ad-hoc correspondence, trial registry registration and updates) of the VM-CTU for all supported trials - estimated 5 trials per annum. Work with trial study coordinators to obtain necessary documents for submission. Coordinate regulatory activities with VM-CTU project manager and protocol development specialist to meet regulatory submission deadlines. Work with individual trial Principal Investigators for development, regulatory submissions, distribution of clarification memos, letters of amendment, and maintenance of read acknowledgements. Liaise with regulatory and ethics authorities for administrative matters. Maintain eTMF for each clinical trial supported by the VM-CTU, including CV updates and GCP training certification tracking. Maintain Standard Operating Procedures Masterfile for the VM-CTU. Oversee the development of the Trial Monitoring Plans for each trial in conjunction with the Clinical Research Associate and track monitoring reports and resolution of findings with site study coordinators. Prepare reports in accordance with funder, sponsor, and regulatory body requirements.

Desired Experience & Qualification

Minimum Requirements

Master's Degree in Science, Medicine, Microbiology, Public Health, or associated allied health professions. At least 2-3 years demonstrable experience in preparing regulatory (SAHPRA) and ethics submissions, report writing, including submitting and tracking routine and expedited safety reports. Previous clinical trial conduct experience. Experience with Drug Safety Update Reporting (DSUR) for SAHPRA. Experience with SANCTR, PACTR, and ClinTrials.gov submissions. Demonstrable experience with Trial Master File (TMF) and Investigator Site File (ISF) set up and maintenance. ICH (R3) and SA GCP certification. Computer literate with advanced skills in MS Office and MS Project. Previous eTMF or eISF software experience is advantageous.
Job Types: Full-time, Permanent

Work Location: In person