Gauteng: Regulatory and Compliance Officer – (FTC – Wits RHI) posted by AJ Personnel

About the Role

The Gauteng Regulatory and Compliance Officer role is an exciting opportunity for a motivated individual to join the Wits Health Consortium team as a full-time employee. As a key member of the Clinical Research Centre, you will be responsible for ensuring compliance with regulatory and good clinical research practice requirements within research studies.

Key Responsibilities

• Prepare applications and submissions to IRB’s, 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 and provide expert guidance on the requirements of local and international regulatory bodies and frameworks and support the department to comply with those requirements
• Track annual recertification submissions to HREC
• Review systems and recommend improvements to streamline the creation and maintenance of trial documentation and review and advise on improvements and standardisation of quality control and assurance systems with respect to improved compliance with regulatory frameworks
• Actively participate in the submission of research protocols and where appropriate assist in writing funding proposals for improvements of monitoring, evaluation and quality control of data
• Ensure site delegation logs are updated when there are staffing changes
• Ensure adequate training completed by staff members and training logs completed
• Ensure staff adhere to responsibilities defined in site delegation logs per qualifications and training
• Ensure that all SOPs have been read and signed by all staff
• When SOPs revised circulate new signage sheets for completion on review
• Prepare site informed consent forms and prepare, review and revise standard operating procedures per study specific needs
• Review and ensure that the study has all essential regulatory documentation
• Assist sponsors / monitors before, during and after the review
• Perform duties per study Delegation of Authority Logs
• Ensure participants are enrolled per defined eligibility criteria
• Provide training to staff in areas of expertise to reduce repetitive errors noted during study file review
• Assist in completion of corrective action for both internal and external monitoring reviews
• Ensure site is well prepared for internal and external lab, pharmacy, clinical, social science and community monitoring reviews
• Ensure documentation is adequate on study specific procedures
• Assess compliance to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and Regulatory Essential Documents per sponsor requirements and to determine the accuracy of research records
• Take ownership and accountability for tasks and demonstrates effective self-management
• Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
• Maintain a positive attitude and respond openly to feedback
• Take ownership for driving own career development by participating in ongoing training and development activities such as conferences, workshops etc

Requirements

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