SUMMARY:
A Study Coordinator (Fixed Term Contract) vacancy is available at our Client, Wits Health Consortium's Clinical HIV Research Unit (CHRU) in Khayelitsha - Western Cape.

POSITION INFO:

Background

The Clinical HIV Research Unit (CHRU) was initiated in 1998 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.

The CHRU is proudly the first International Clinical Research Site (CRS) of the AIDS Clinical Trials Group (ACTG).  To date, it remains one of the most successful international sites within the ACTG.  The site is substantially funded by the National Institutes of Health (NIH) and USAID/PEPFAR.

Based at the Helen Joseph Academic Hospital in Johannesburg, the CHRU conducts research into HIV-AIDs, carrying out clinical trials that encompass associated dread diseases (TB, Cervical Cancer and other opportunistic infections) and provides technical expertise and assistance, training of health care personnel, quality assurance assessments of sites, and clinical support services

Main purpose of the job

• To be responsible for coordinating all the trial/program activities that result in the smooth running of a clinical research project

Location

• MSF Khayelitsha, Western Cape

Key performance areas

• Identify participants
• Education of protocol to participants
• Scheduling/booking patients
• Collecting of medical history data from participant and hospital records
• Compilation of research documentation
• Informed consent process
• Make informed consent copies as per Unit SOP
• Confirm participant details
• Ensure that all study procedures are fulfilled
• Allocate patient identification number
• Submit a request to the National Clinical Advisory Committee (NCAC) of eligible participants and ensure approval prior to enrolment
• Assessing inclusion and exclusion criteria in relation to protocol requirements
• Ensure that all study procedures are fulfilled
• Do scheduled and follow up visits
• Management of routine visits and care
• Follow up on participants with adverse reactions or abnormal results
• Follow up of participants with missed visits
• Sample collection
• Perform specific clinical procedures e.g. ECGs
• Processing of samples and maintenance of sample logs
• Maintenance of clinical and laboratory equipment and supplies
• Assist the site pharmacist in ensuring correct drug dispensing, drug accountability, participant counseling and monitoring of drug adherence
• Ensure that data is eligible, attributable, and of good quality
• Enter eCRF data within protocol required timelines
• Perform QC activities on source and data entries
• Resolve data queries and corrections within a specified time frame
• Perform data cleaning tasks in preparation for Data Monitoring Committee meetings
• Maintenance of documentation for the Investigator Site Files
• Preparation of regulatory files prior to protocol implementation
• Liaise with the QC/QA Officer to ensure all site-specific regulatory requirements are continuously met
• Continuous updating of screening/enrolment and delegation logs 
• Updating of progress reports
• Reporting of SAE / AE within required timelines
• Reporting of protocol violations and deviations
• Preparation of source documentation and Investigator Site Files prior to audits and monitoring visits

Required minimum education and training

• Diploma/Degree in medical field
• Good Clinical Practice certificate preferred

Desirable additional education, work experience and personal abilities

• Individual must have attention to detail, leadership and interpersonal relationships
• Accountability and the ability to work under pressure so as to adhere to strict timelines is of major importance
• Competent in the use of Microsoft Office packages (Word, Excel, Outlook)
• Maintenance of confidentiality will be required

Required minimum work experience

• 1-2 years’ of work experience in a clinical research field
• 3-5 years’ work experience for non-interventional studies
• 1 years’ experience in a TB Clinic

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 20 January 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.