Job Description

Main purpose of the job:

• To manage the submissions and administration of regulatory and essential documents to all required Ethics Committees (EC) and regulatory bodies such as the South African Health Products Regulatory Authority (SAHPRA), Biobank Ethics Committee; Department of Health; SANCTR; PACTR, etc.
• To monitor and ensure compliance with regulatory and Good Clinical Practice (GCP) requirements within research studies

Location:

• Hillbrow - Johannesburg (Ward 21 CRS and affiliated sites)

Key performance areas:Regulatory Submissions

• Submit regulatory applications in a timeous and accurate manner (this includes, amongst others, initial protocol and protocol amendment applications, recertifications, informed consent forms updates, progress reports, investigator applications, any other required correspondences to Ethics Committees, Regulatory Authorities and Dept. of Health/Gauteng Province/Johannesburg Health District
• Maintain Investigator site files (ISF) and all study essential documents according to site or sponsor Table of Contents, SOPs, SA GCP, and ICH
• Track all approvals, acknowledgments/favorable opinions, recertifications, translations, insurances, ICFs, LOAs, CMs, etc.
• Maintain tracking logs and systems for all submissions and approvals/acknowledgments, study staff documentation, and other essential documents in the ISF
• Create and/or provide study teams with current regulatory templates
• Complete non-CTU regulatory fees spreadsheets for finance monthly (to be sent to finance within two weeks of month-end)
• Assist in troubleshooting and rectifying process flow problems in the regulatory process
• Report and track critical events and protocol deviations - adhere to EC, SAHPRA, and Sponsor timelines of reporting
• Safety updates: Ethics and SAHPRA line listings, submissions, and updating tracking logs
• Assist with site monitoring visits and audits/inspections preparation
• Participate in site monitoring visits and any audits/inspections

Quality management

• Draft and review SOPs
• Conduct internal monitoring: regulatory file/ISF reviews per the Clinical Quality Management Plan (CQMP)
• Prepare internal regulatory review reports per required templates (CQMP)
• Maintain internal regulatory review files
• Assist with preparation and follow-up of monitoring visits and audits
• Training/corrective action for site staff based on QC/QA/External monitoring findings
• Maintain monitoring files

Staff Management (when required)

• Ensure that 1-2-1 discussions are conducted with all staff regarding performance
• Ensure at least annual performance appraisals and probationary reviews are conducted with the regulatory administrator
• Ensure corrective action is implemented in terms of the code of conduct and in consultation with HR
• Ensure efficient manpower planning on a daily basis

Required minimum education and training:

• Graduate degree in Science, Allied Medical Sciences or related degree

Required minimum work experience:

• At least 3-5 years experience in a clinical trial environment

Desirable additional education, work experience, and personal abilities:

• Good Clinical Practice; Human Subjects Protection; experiences with DAIDS sponsored trials
• Must have excellent knowledge and understanding of the Local Ethics and Regulatory requirements, as well as that of the FDA, NIH/DAIDS, OHRP, and EMA
• Familiar with local and sponsor websites and resources e.g., DAIDS websites, HANC or networks, Wits HREC, WHREC BEC, SAHPRA, DoH, NHRD, PACTR, SANCTR, etc.
• Understanding of research language and essential documents management and maintenance
• Detailed knowledge of regulatory application and approval processes
• Computer literate: MS Word, excel, TEAMS, and other databases
• Attention to detail.; organizational skills and problem-solving skills
• Ability to work independently but must be a team player
• Assertive; Ability to delegate if required; Proactive; Innovative; Flexible, Ability to guide and train study teams, understand the goals of projects and the unit
• Maintain a positive attitude and respond openly to feedback
• Take ownership of driving own career development by participating in ongoing training and development activities such as conferences, workshops, etc.

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: 17 November 2021.
• 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:

• 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.

AJ Personnel