Quality Assurance Officer x2: DPP/SAMURAI FTC/RHI

 

Recruiter:

AJ Personnel

Job Ref:

JHB002861/EvdM

Date posted:

Monday, January 25, 2021

Location:

Hillbrow, South Africa

Salary:

RNEG Monthly


SUMMARY:
A Quality Assurance Officer x 2: DPP & SAMURAI Study - (Fixed Term Contract) vacancy is available at our Client, Wits Health Consortium's Reproductive Health and HIV Institute (RHI) in Hillbrow - Johannesburg.

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

  • Ensure QA and QC activities performed effectively across studies
  • Where trends identified, coordinate relevant staff training

Location

  • 7 Esselen Street, Research Centre, Hillbrow

Key performance areas

  • Review and ensure that the study has all essential regulatory documentation through routine updates as needed
  • Assist with the review and revision of standard operating procedures per study-specific needs as needed
  • Assist Regulatory Compliance Manager/Officer with QA of Regulatory files
  • Verify transcription and accuracy of data from source documentation to Case Report Forms (CRF)
  • Ensure errors on CRF’s are corrected, initialed and dated by the authorized signatory
  • Support the timely transmission/data faxing/data entry of relevant Case Report Forms following QC activity (as needed)
  • Ensure completion of corrective action of internal and QC reports/error trends identified during QC
  • Assist in completion of corrective action for internal monitoring reviews
  • Coordinate staff training (and retraining) where error trends are identified
  • QC of Informed Consent Forms and other source documents to ensure accuracy and completeness
  • Timeous reporting to project investigator/study coordinator or designee regarding QC trends and major issues
  • Support periodic quality assurance activities as per the CQMP
  • Assess staff awareness and compliance to Good Clinical Practice (GCP), Protocol requirements, Standard Operating Procedures (SOPs) and Regulatory Essential Documents per sponsor requirements
  • Determine through critical review the accuracy of research records
  • Compile QA/QC report/s on findings for the site management team
  • Assist in completion of corrective action for internal monitoring reviews
  • Coordinate staff training (and retraining) where error trends are identified
  • Ensure 100% QA of ICFs
  • Ensure the site is well prepared for external lab, clinical, social science and data monitoring reviews
  • Assist sponsors/monitor/auditor before, during and after the review
  • Assist regulatory compliance manager, project managers/team in completion of corrective action for external monitoring reviews/audit and inspections
  • Take ownership and accountability for tasks and demonstrates effective self-management
  • Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
  • Maintain a positive attitude and respond openly to feedback
  • Take ownership for driving your own career development by participating in ongoing training and development activities such as conferences, workshops, etc.

Required minimum education and training

  • 3-year diploma or degree in a health-related field

Desirable additional education, work experience and personal abilities

  • A post-graduate degree in Quality Management would be an added advantage
  • Understanding of the research language, detailed knowledge and understanding of the relevant studies and SOPs, knowledge of clinical research documentation
  • Computer literate with the ability to create or work with relevant data sets
  • Fluent in English, fluency in one of the other official SA languages particularly Zulu or Sesotho would be an added advantage
  • Good written and verbal communication skills
  • Strategic thinking and problem-solving skills
  • Conscientious and precise delivery of work even when under pressure
  • Effective self-management, resourcefulness and initiative to solve problems
  • Excellent communication and presentation skills

Required minimum work experience

  • Minimum 1-2 years relevant work experience within a clinical research environment in Quality Control and Quality Assurance

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 02 February 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 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. 



 

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



 

 

 

Similar jobs you might be interested in:

Quality Assurance Officer (Laboratory) Wits VIDA
Location: Soweto
Salary:
14 days ago


Senior Quality Assurance Technician
Location: Boksburg
Salary: Market related
To ensure effective quality assurance through the effective execution of raw materials quality
1 day ago


Jnr Quality/Assurance ANALYST
Location: Johannesburg
Salary: Monthly
Jnr quality/assurance ANALYST(MUST currently work as an Analyst with Minimum 1-2 Year's experience in the FMCG Industry)- Nasrec, Jhb area (MUST stay within reasonable distance -    ***Clearly Stipulate if your are Willing to Relocate at Own        Cost on your Resume/CV)
8 days ago


Quality Assurance
Location: Johannesburg
Salary:
Must possess a suitable tertiary qualification in engineering / quality control / management qualification or equivalent would be an advantageMinimum of 3 years’ experience in the engineering / construction sector is required    
11 days ago


Lead: Quality Assurance
Location: Pretoria
Salary: 65000 Monthly
Our client is looking for a Lead: quality assurance to be based in Pretoria. Head Chapter Lead – QA is a leadership role, accountable for the successful QA implementation of QA methodologies, process and automation technologies within DevOps & Agile Principles. You will manage a team of 10 - 15 QA Testers. Send your CV now!
15 days ago


National Manager: Quality Assurance (Health/Laboratory Services)
Location: Johannesburg
Salary:
15 days ago


National Quality Assurance Manager
Location: Johannesburg
Salary:
16 days ago


National Manager: Quality Assurance
Location: Johannesburg
Salary:
15 days ago


IT Quality Assurance Manager
Location: Johannesburg
Salary:
Looking for an incredible IT quality assurance Manager who is looking for a new career adventure and is based in Johannesburg. If this sounds like you, then this could be the perfect opportunity for you.
22 days ago


Software Quality Assurance and Support Team Lead
Location: Johannesburg
Salary: R70 000.00 Monthly
To all the Data Engineers, would you be interested in a new career advancement opportunity? With a distinctive touch-and-tech strategy that combines excellent technology with friendly human encounters, our client is backed by powerful industry leaders and is revolutionizing credit in Africa.
24 days ago


Create a free job alert for Quality Assurance Officer x2: DPP/SAMURAI FTC/RHI in Hillbrow

Enter your email address below and we will email you similar jobs when they become available:

You can cancel at any time. We will not spam you.
By giving us your email address your agree to our Terms and Conditions