Hillbrow: Regulatory and Compliance Officer – (FTC – Wits RHI)

About the Role

The Regulatory and Compliance Officer role at the Clinical Research Centre Location, 7 Esselen Street, Hillbrow, Wits RHI Research Centre is a critical position that monitors and ensures compliance with regulatory and good clinical research practice requirements within research studies. The successful candidate will be responsible for preparing applications and submissions to relevant authorities, creating and maintaining regulatory systems, and providing expert guidance on regulatory requirements.

Key Responsibilities

• Prepare applications and submissions to IRBs, SAHPRA, DOH, NHRD as needed
• Create, establish and maintain regulatory systems for Wits RHI studies per SAHPRA, HREC, sponsor and DOH requirements
• Print and file regulatory documentation
• Work with the Regulatory Oversight Group (ROG) and Research Review Committee (RRC) as needed
• Provide expert guidance on local and international regulatory bodies and frameworks
• Track annual recertification submissions to HREC
• Recommend improvements to streamline trial documentation creation and maintenance
• Advise on quality control and assurance systems
• Participate in the submission of research protocols and funding proposals
• Update site delegation logs with staffing changes
• Ensure adequate training completed by staff members and training logs completed
• Ensure staff adhere to responsibilities defined in site delegation logs
• Review and ensure study has all essential regulatory documentation
• Perform duties per study
• Delegation of Authority Logs
• Enroll participants per defined eligibility criteria
• Provide training to staff in areas of expertise
• Assist in completion of corrective action for internal and external monitoring reviews
• Ensure site is well prepared for lab, pharmacy, clinical, social science and community monitoring reviews
• Assess compliance to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and Regulatory Essential Documents per sponsor requirements

Requirements

• 3 year Degree in a Health related field
• Minimum 1-3 years relevant work experience within a clinical research environment in regulatory compliance

Qualifications

No qualifications mentioned.

Salary & Benefits

No salary or benefits information provided.