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Regulatory Manager
Main purpose of the job
To ensure compliance with relevant regulatory authorities according to good clinical practice (GCP) requirements in the
Research Center and Yeoville CRS with specific focus on Network Trials.
Location
Hillbrow, Research Centre
Key performance areas
 Regulatory Support o To create, establish and maintain regulatory systems for Wits RHI studies per MCC, WHREC, sponsor (NIH;
DAIDS) and DOH/CoJ requirements o Provide expert guidance on the requirements of local and international regulatory bodies and frameworks, and support the Research Centre and Yeoville CRSs to comply with those requirements where appropriate o Review and ensure that the study has all essential regulatory documentation o Actively participate in the submission of research protocols where appropriate assist in writing funding proposals for improvements of monitoring, evaluation and quality control of data o Manage and/or prevent any regulatory-related problems or issues that arise
 Conduct internal monitoring and quality assurance activities o Develop, review/update and implement Clinical Quality Management Plan and provide training to the team o Review and advise on improvements and standardisation of quality assurance systems o Conduct internal monitoring and quality assurance which includes review of participant eligibility criteria, informed consents, etc. o 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 o Provide internal monitoring and QA reports / feedback on findings for site management team o Assist in completion of corrective action for internal monitoring reviews o Provide training to staff and students in areas of expertise to reduce repetitive errors noted during study file review o Work with project managers to ensure adequate quality-related training completed by new staff members and training logs completed o Update site delegation logs when new staff join and check that staff adhere to responsibilities defined in site delegation logs o Document control: Ensure that all SOPs have been read and signed by all staff and when SOPs are revised circulate new signage sheets for completion on review o Prepare, review and revise regulatory and quality related SOPs per study specific needs

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 External Monitoring o Ensure site is well prepared for external lab, pharmacy, clinical, social science and community monitoring reviews o Assist sponsors/monitors before, during and after the review o Lead completion of corrective action for external monitoring reviews
 Staff management o Attend to all staffing requirements and administration o Supervise and manage the duties of subordinates to ensure optimal staff utilisation and maintenance of sound labour relations
Required minimum education and training
 3 year diploma or degree in a health related field
Required minimum work experience
 Minimum 4 years relevant work experience within a clinical research environment
Desirable additional education, work experience and personal abilities
 A post graduate qualification in Quality Management. Certification in good clinical practice (GCP) and regulatory knowledge. Understanding of the research language, detailed knowledge and understanding of the relevant studies and SOPs, knowledge of clinical research documentation. Detailed knowledge of regulatory application and approval processes. High level of attention to detail. Staff management or supervisory experience. Good interpersonal skills and ability to navigate complicated situations
 Excellent levels of written and verbal English communication skills and ability to communicate in other SA languages, preferably must be area appropriate
Should you be interested in applying for this vacancy, clearly state which vacancy you are applying for and forward your detailed CV to: Lungile Vilakazi at lvilakazi@witshealth.co.za or fax to 0867689817
The closing date for all applications is 11 August 2014
The Wits RHI will only respond to shortlisted candidates. Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful. In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.