Regulatory Manager (Wits VIDA)

Main purpose of the job:

• To manage ethics and regulatory affairs, providing unit-wide support for regulatory files, ethics submissions, quality framework, and ensure compliance with relevant bodies, Good Clinical Practice, unit and research project standards

Location:

• Wits VIDA Research Unit - Chris Hani Baragwanath Academic Hospital & Rahima Moosa Mother & Child Hospital – Soweto/Johannesburg

Key performance areas:

Regulatory Management

• Identify, compile and submit all relevant information necessary to obtain regulatory approvals for research studies
• Maintain regulatory files, prepare collations and copies for various submissions
• Update and maintain CVs, certificates, and registrations i.e. GCP, HPCSA, SAPC, SANC, MPS, etc.
• Monitor annual submission cycles to ensure recertification of submissions
• Devise and update tracking tools/logs and systems for regulatory submission documents
• Compile relevant progress reports as well as unit-wide project management of regulatory submissions and maintenance
• Report adverse events to Ethics and SAHPRA as required
• Provide safety updates to required regulatory bodies throughout studies
• Support unit research teams to update, maintain and control all Informed Consent forms and versions
• Develop, maintain and implement Regulatory SOP and maintain records and updates on all unit SOPs
• Oversee capture and update all relevant study information on relevant websites/registries
• Advice and assist with Investigator Driven/Grant Funded protocols and submissions as required

Quality Control and Quality Assurance

• Quality assures all regulatory files prior to monitoring visits, working with applicable site teams
• Collaborate with QC and administration teams to conduct internal monitoring regulatory file reviews regularly/every quarter
• Review and analyze reports
• Review and monitor logical checks, queries, and error trends and make relevant recommendations
• Capture data and respond to queries on respective systems
• Provide training to Data Management and relevant teams as may be required
• Participate in internal and external monitoring visits and audits
• Contribute to unit Quality Assurance and Quality Control management (assist to establish and coordinate a committee)

Administration

• Effective administration and management of Ethics and Regulatory team annual budgets and efficient management and records of submissions fees, collaborating with finance
• Collaborate on the preparation of study budgets if needed
• Support study financial control/management as required (invoices, tracking payments)
• Liaise and correspond with laboratories as required
• Distribute protocols to staff members as required
• Maintain web-based communications and respond to monitoring authorities to address queries
• Oversee coordination of training meetings and attendance for GCP courses
• Support with preparation of reports and documentation for donors/funders

Staff Management

• Attend to all staffing requirements and administration
• Supervise and manage the duties of permanent and fixed-term or ad hoc team members to ensure optimal staff
• Consistent application of sound labor relations
• Perform and facilitate performance development and assessments
• Identify substandard performance by team members and take necessary corrective action
• Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization
• Promote harmony, teamwork, and sharing of information

Required minimum education and training:

• Grade 12 + Relevant diploma or degree (Science, Allied Medical Sciences, Pharmaceutical or similar)
• Advanced level of Microsoft Office

Required minimum work experience:

• Minimum 4 years of relevant work experience within a clinical research environment; management/coordination or similar experience

Desirable additional education, work experience, and personal abilities:

• Must be willing to work after hours when needed
• Knowledge of the use of chemical substances, radioactivity, and safe laboratory practice, and knowledge of health and safety regulations
• Self-starter with excellent time management skills and the ability to take initiative
• Good communication & training skills
• Ability to organize own workload under the direction of academic staff
• Ability to work as an individual and part of a team
• Adaptability, high degree of technical competence, ability to multi-task to meet all research needs
• Operation of specialized equipment, requiring specialist training
• Computer literacy
• Able to work shifts

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: 20 April 2022.
• 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 1998 and subsequent amendments thereto.
• PLEASE NOTE: Our Client, WHC - VIDA, 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 advertising the advertisement on behalf of their client Wits Health Consortium.
• AJ Personnel does not have any salary or other information regarding the position.