DTHF: Internal Monitor

Desmond Tutu HIV Foundation (DTHF)
Please note: this opportunity closing date has passed and may not be available any more.
Opportunity closing date: 
Friday, 21 July, 2017

The Desmond Tutu HIV Foundation (DTHF) is a registered nonprofit organisation focused on the pursuit of excellence in research, treatment, training and prevention of HIV and related infections in Southern Africa.

DTHF seeks to appoint an Internal Monitor to be based in Cape Town. 

Duration: One year fixed-term contract
 
The function of this position will be to carry out aspects of quality assurance, including auditing study team compliance with required study procedures and Clinical Practice standards in order to verify that all research guidelines and regulations are adhered to.

Responsibilities:

  • Monitor adherence of Clinical Research Sites (CRSs) to data quality management plans
  • Report on effectiveness of Quality Management plans
  • Conduct six monthly reviews of the regulatory files
  • Ensure that all documents that require ethics and regulatory review are submitted timeously and have approvals in place
  • Ensure staff documentation is adequate and up to date
  • Ensure that necessary communications have been filed
  • Ensure that all regulatory progress reports are on file
  • Ensure that all documentation is file according to ICH/GCP and sponsor requirements
  • Review regulatory trackers and give input for the design of regulatory trackers when needed
  • Ensure corrective action is implemented
  • Review QC and QA reports and monitoring reports to identify trends
  • Review CRS Bi-annual QA Reports and submit to DAIDS as per policy
  • Liaise with the CTU QA Manager, support and advise the PI, study team at sites in the conduct of QC and QA activities and policies
  • Conduct six monthly reviews of the regulatory files
  • Ensure that all documents that require ethics and regulatory review are submitted timeously and have approvals in place

Requirements: 

  • Matric plus a documented qualification preferably in a Health related field
  • Three years’ experience in working with complex multiple research studies
  • Knowledge of Good Clinical Practice (GCP) guidelines and clinical trial site processes
  • Computer literacy: MS Office, Microsoft Outlook 
  • Clinical trial operations expertise
  • In depth understanding and knowledge of Division of AIDS (DAIDS) Networks and study data management would be an advantage
  • Thorough understanding of Regulatory processes (HREC, MCC, NHREC, etc.)
  • Communication skills (English written and verbal)
  • Sound technical knowledge and skills 
  • Strong client focus
  • Ability to build interpersonal relationships and partnerships
  • Strong problem-solving and decision-making abilities 
  • Attention to detail
  • Planning and organisation abilities
  • Values fit; Passion, Innovation, Progress, Integrity, Respect, Excellence

To apply, quote Job reference, submit CV, motivation letter with certified copy of identity document and highest qualification; including details of three current contactable referees to: Attention HR Manager Jobs@hiv-research.org.za by 21st July 2017.

Job reference: #DTHF/C087

Please quote the source of this advertisement in your application - NGO Pulse Portal

Only shortlisted candidates will be contacted. 

DTHF is committed to equity in our employment practices. 

It is with intention to appoint individuals with the aim of meeting our equity objectives.
 
DTHF reserve the right not to appoint if no suitable candidates are identified.

This job may be removed before it expires.

If you are a foreign national applying for this position, please attach a copy of your work permit to your application.

If you do not receive a response within two weeks after the closing date, please consider your application as unsuccessful.

Desmond Tutu HIV Foundation is a child friendly organisation committed to the protection of children.

For more about the Desmond Tutu HIV Foundation, refer to www.desmondtutuhivfoundation.org.za

For other vacancies in the NGO sector, refer to www.ngopulse.org/vacancies

Location: 
Cape Town

NGO Services

NGO Services