SUMMARY:
A Regulatory Manager vacancy is available at our Client, Wits Health Consortium's Reproductive Health and HIV Institute (RHI) in Hillbrow, Johannesburg - Gauteng.

POSITION INFO:

Background

The Wits Reproductive Health and HIV Institute (Wits RHI) is a renowned African-led research institute that seeks solutions to Africa’s health challenges.

It is located within the University of the Witwatersrand and addresses some of the greatest public health concerns affecting our region, including HIV and its related problems, sexual and reproductive health and vaccinology. This is done through pioneering, multi-disciplinary research; responsive technical support and innovation in health services; and evidence-based policy development and advocacy with national, regional and global stakeholders

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 Medicines Control Council (MCC), Institutional Biosafety Committee (IBC), administrative departments for Genetically Modified Organisms (GMO) or any other sponsor group
• This must be done in accordance with the protocol, Good Clinical Practice (GCP) and Sponsor requirements 

Location

• Hillbrow - Wits RHI Research Centre

Key performance areas

• Submit regulatory applications in a timeous and accurate manner (this includes amongst others initial protocol and amendment applications, re-certifications, information updates, progress reports, investigator applications, IBs and PIs updates
• Distribute requests for information and approvals within two business day of receipt
• Maintain regulatory documents in three locations
• Study Regulatory File (originals, faxes, email printouts, correspondence, etc.)
• Regulatory Files (copies of pertinent submission and approval letters)
• Shared Drive (all documents and correspondence)
• Maintain SOP file and listing
• Attend bi-weekly regulatory meetings with study teams to provide regulatory updates and follow-up
• Participate in study team meetings as required and provide constructive feedback and support to other team members
• Maintain tracking logs and systems for all submissions
• Assist with preparation and follow-up of monitoring visits and audits
• Conduct internal monitoring regulatory file reviews on a quarterly basis
• 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
• Training/corrective action for site staff based on QC/QA/External monitoring findings
• Track protocol approvals, recertification’s, translations, insurances, ICFs, LOAs, CMs and all other study documents
• Report and track critical events and protocol deviations – adhere to EC, MCC and Sponsor timelines of reporting
• Develop and/or review study-specific SOPs when required
• Generate performance reports on studies monthly 
• Provide monitoring visit follow-up reports and follow-up letters to the site staff
• Track protocol approvals, recertification’s, translations, insurances, ICFs, LOAs, CMs and all other study documents
• Report and track critical events and protocol deviations – adhere to EC, MCC and Sponsor timelines of reporting
• Develop and/or review study-specific SOPs when required
• Generate performance reports on studies monthly 
• Provide monitoring visit follow-up reports and follow-up letters to the site staff
• Take ownership and accountability for tasks & activities and demonstrates effective self-management
• Inform relevant parties in the event of tasks or deadlines not met and provide appropriate means of resolution
• Support and drives the business’ core values
• Maintain a positive attitude
• Take ownership for own career development
• Manage colleagues and client’s expectation and communicate appropriately
• Willing to help others and go the extra mile to meet team targets and objectives
• Be resourceful and efficient with managing the regulatory department

Required minimum education and training

• 3 Years Diploma or Degree in a health-related field

Desirable additional education, work experience and personal abilities

• Good Clinical Practice
• Human Subjects Protection
• OHRP and ongoing training modules on DAIDS Learning Management System
• Time Management
• Writing and presentation skills
• 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 for HANC or networks, Wits HREC, MCC, DAFF, etc.
• Attention to detail
• Organizational skills
• 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

Required minimum work experience

• At least 3 years of experience in a Clinical Trial environment

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
• 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 is 11 May 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.
• 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.

Please note that 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.

NB! This job is now closed. You can apply for other jobs by uploading your CV.