Regulatory Office Assistant
  • Pietermaritzburg, KwaZulu-Natal
  • HSRC Recruitment
Job Description

Job Advert Summary

The CCBR seeks to appoint suitably qualified persons to take on the responsibilities of a Regulatory Coordinator for projects implemented at the Sweetwaters office. The successful candidate will work across research projects being conducted on site.

The Regulatory Coordinator will report to the Clinical Research Director and site principal investigators. This position is offered on a 13 Month contract.

Minimum Requirements

Minimum requirements:

  • A 3 year degree or diploma in the social and human sciences or related fields or relevant certification, qualification or experience
  • 1-2 years’ regulatory exposure to clinical research projects involving human subjects
  • Current GCP certificate
  • Ability to use Microsoft Word
  • Good interpersonal, organisational and problem solving skills
  • Ability to work accurately, independently and in a team
  • Ability to work to strict deadlines and attention to detail

Preference will be given to candidates who have:

  • Legal understanding
  • Commitment to working as part of multi-disciplinary research team;
  • Willingness to work after hours and over weekends and in rural communities

Applicants will be required to take a practical skills assessment test as part of the interview process.

Duties and Responsibilities

Key responsibilities:

  • Prepares and maintains IRB submissions and Regulatory documents
  • Monitors and maintains Standard Operating Procedures (SOPs) across studies
  • Uphold the code of ethics in regards to medical science and human subjects.
  • Monitor trial procedures
  • Observe conduct to evaluate ethical code adherence
  • Submit data and findings reports to regulatory agencies.
  • Tracks study progress in Clinical Trial Management systems
  • Act as a liaison for regulatory agencies and effectively impart information to the clinical trial managers.

Additional Responsibilities:

  • Must be able to keep track of multiple streams of information.
  • Must also be able to clearly and accurately record this information
  • Must also be able to generate verbal and written reports of your observations.
  • Must be able to operate a number of computer systems for tracking data and generating reports and presentations.

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