We are looking for a highly capable administrative professional based in South Africa who can work US EST business hours. This role is perfect for someone with a strong background in complex documentation, administrative coordination, and compliance who is ready to dedicate themselves to mastering the regulatory demands of US clinical trials.
Transferable Skills We Need
- Exceptional Administrative Command : Proven experience in managing complex administrative processes, including detailed filing, data capturing, document control, and compiling comprehensive submissions (e.g., quotations, tender submissions, legal documents).
- System & Technology Mastery : Rapid ability to learn and implement specialized software and systems. Experience with platform-based training and certification (e.g., CRIO, Medidata, Shadowmatch) is highly valued.
- Process & Coordination Ownership : Demonstrated capacity to manage end-to‑end processes independently, from coordinating bookings and logistics (flights, hotels, assessments) to resolving queries and liaising with multiple parties (clients, consultants, suppliers).
- Compliance & Detail Orientation : Track record of meticulous attention to detail required in high‑stakes environments, such as managing finances, controlling quality, tracking inventory, and ensuring all documentation is filed correctly.
The Role's Trajectory : Becoming the Regulatory Expert
CRIO System Administration : Rapidly learn to configure and manage studies within CRIO (eReg, eSource, CTMS). Proficiency in achieving complex certifications (like the CRIO suite) will be key.Regulatory Start‑Up Coordination : Master the process of clinical trial start‑ups, including collecting essential staff documentation, managing signature assignments, and compiling full submission packages for sponsors / CROs.Documentation & File Maintenance : Apply strong filing and organizational skills to setting up and maintaining audit‑ready Investigator Site Files (ISF), ensuring version control, and maintaining ease of document location.Team & System Onboarding : Manage role‑based study training logs and oversee staff onboarding, including technical setup and access management.Compliance Monitoring : Review temperature logs, ensure investigational product storage specifications are met, and verify patient visit completion.The Offer
100% Remote Contract : Work from anywhere in South Africa.Competitive Rate : Paid for US hours coverage.US Exposure : Direct collaboration with US systems and clinical operations.Please send your resume to with the subject "Clinical trials regulator".
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