Regulatory Compliance Officer - Hillbrow, South Africa - AJ Personnel

AJ Personnel

Verified Company

Hillbrow, South Africa

1 week ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Main purpose of the job:

To monitor and ensure compliance with regulatory and good clinical research practice requirements within research studies within the Research Centre in Johannesburg

Location:

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Wits RHI - 7 Esselen Street, Hillbrow, Research Centre. On the 3rd ,4th, and 5th Floor

Key performance areas:

Create, establish, and maintain regulatory systems for Wits RHI studies per SAHPRA, HREC, sponsor, and DOH requirements. Print and file regulatory documentation
Work with the Regulatory Oversight Group (ROG) and Research Review Committee (RRC) as needed and provide expert guidance on the requirements of local and international regulatory bodies and frameworks and support the department to comply with those requirements
Track annual recertification submissions to HREC
Review systems and recommend improvements to streamline the creation and maintenance of trial documentation and review and advise on improvements and standardization of quality control and assurance systems with respect to improved compliance with regulatory frameworks
Actively participate in the submission of research protocols and where appropriate assist in writing funding proposals for improvements in monitoring, evaluation, and quality control of data
Ensure site delegation logs are updated when there are staffing changes
Ensure adequate training is completed by staff members and training logs completed
Ensure staff adhere to responsibilities defined in site delegation logs per qualifications and training
Ensure that all SOPs have been read and signed by all staff. When SOPs are revised circulate new signage sheets for completion on review
Prepare siteinformed consent forms and prepare, review, and revise standard operating procedures per studyspecific needs
Review and ensure that the study has all essential regulatory documentation
Assist sponsors/monitors before, during, and after the review
Perform duties per study Delegation of Authority Logs
Ensure participants are enrolled per defined eligibility criteria
Provide training to staff in areas of expertise to reduce repetitive errors noted during the study file review
Assist in the completion of corrective action for both internal and external monitoring reviews
Ensure the site is well prepared for internal and external lab, pharmacy, clinical, social science, and community monitoring reviews
Ensure documentation is adequate on studyspecific procedures
Assess compliance to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and Regulatory Essential Documents per sponsor requirements and determine the accuracy of research records
Take ownership and accountability for tasks and demonstrates effective selfmanagement
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 of driving your own career development by participating in ongoing training and development activities such as conferences, workshops, etc.

Required minimum education and training:

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3-year Diploma or Degree in a health-related field

Required minimum work experience:

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Minimum 3 years of relevant work experience within a clinical research environment in regulatory compliance

Desirable additional education, work experience, and personal abilities:

A postgraduate 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 databases
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 problemsolving skills
Conscientious and precise delivery of work even when under pressure
Effective selfmanagement, resourcefulness, and initiative to solve problems
Excellent communication and presentation skills

TO APPLY:

Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
Note AJ Personnel is fully POPI compliant.
Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.

Please note:

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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.