Regulatory Manager (Wits Chru)


*Background* The Clinical HIV Research Unit (Wits CHRU) was initiated in by Professor Ian Sanne, under the auspices of the University of the Witwatersrand (WITS). Today the CHRU is an HIV/AIDS, TB, and Cervical Cancer research syndicate of the Wits Health Consortium (Pty) Limited (WHC), which is a wholly-owned subsidiary company of WITS*.**Main purpose of the job:* * To manage the CHRU Regulatory Department * Responsible for submissions, correspondence, and administration of regulatory and essential documents to all required stakeholders: Ethics Committees Medicines Control Council and other regulatory bodies, Institutional Biosafety Committee, Administrative Departments for Genetically Modified Organisms, or any other sponsor group * This must be done in accordance with the protocol, Good Clinical Practice, Sponsor requirements, and CHRU standards *Location:* * *Helen Joseph Hospital, Johannesburg* *Key performance areas:* * Submit regulatory applications in a timeous and accurate manner to all applicable ethics, regulatory bodies, and sponsors * Maintain regulatory documents * Participate in study team meetings as required and provide constructive feedback and support to other team members * Track submissions and approvals * Assist with preparation and follow-up of monitoring visits and audits * Conduct internal monitoring of regulatory files * Create and/or provide study teams with current regulatory templates * Assist in troubleshooting and rectifying flow problems in the regulatory process * Training/corrective action for site staff based on QC/QA/External monitoring findings in conjunction with Project Managers * Report and track critical events and protocol deviations as notifications occur * Develop and/or review study-specific SOPs when required * Generate regulatory reports as required * Create or amend study-specific documents such as Informed Consent Forms per required SOPs * Communication with internal and external stakeholders * Supervise and manage the duties of subordinates *Required minimum education and training:* * *Graduate degree in Science, Social Sciences or Allied Medical Sciences (or equivalent)* * *Computer literacy at a higher level including the use of the MS Windows suite and Internet* * *Certification in Good Clinical Practice (GCP)* *Required minimum work experience:* * *2-3 years management experience working in a similar regulatory role* * *5 years experience in a research environment* *Desirable additional education, work experience, and personal abilities:* * Ability to communicate effectively within study team and with external stakeholders * Very time conscious * Ability to work in a high-pressure environment * Attention to detail * Process orientated * Output driven * Extremely well organized and resourceful * Flexible and able to multitask * Exhibit strong leadership and mentoring skills *TO APPLY:* * Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV. * Please Apply Online and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate to accept the new POPIA terms and conditions. This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL. However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market. * AJ Personnel is fully POPIA Compliant. * Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position. * The closing date for all applications: *31 March *. * Wits Health Consortium 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. * Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of and subsequent amendments thereto. * PLEASE NOTE: Our Client, WHC - CHRU, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions. *Please note:* * AJ Personnel is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium. * AJ Personnel does not have any salary or other information regarding the position. Medical Aid Contribution, Provident Fund Contribution
Posted
05/05/2022
Location
Johannesburg, GT, ZA