Chief Research Technologist

at South African Medical Research Council
Location Durban, Durban, South Africa
Date Posted
Category Healthcare
Job Type FULL_TIME
Work Hours Day
Salary 361043
Salary Units YEAR
Currency ZAR

Description

 

The South African Medical Research Council (SAMRC) strives to improve the nation’s health and quality of life by funding and conducting relevant and leading health research. It further aims to promote equity, career development and progression. The organisation prides itself on six values: pioneering, partnering, excellence, respect, integrity and citizenship.

 

CHIEF RESEARCH TECHNOLOGIST: REGULATORY & QUALITY COORDINATOR

 

Two - Year Contract

 

A committed, motivated, suitably qualified and experienced Regulatory and Quality coordinator is required to work with the Principal Investigators/Support Managers and Clinical Site Research Leaders in coordinating regulatory and quality control/assurance aspects of clinical trials. The individual will be responsible for ensuring compliance with various regulatory authorities and maintaining exceptional data quality control within clinical trials.

 

Responsibilities:

 

Regulatory Coordination:

 

Implementation of systems to ensure regulatory compliance, to local and international guidelines and polices

To prepare protocol submissions for ethical and regulatory approvals for new and existing studies.

To prepare and submit progress reports to South African Health Products Regulatory Authority (SAHPRA) and recertification with Ethics Committees

Co-ordination of all regulatory activities for all studies conducted at the HPRU, across research sites

Ensuring adequate follow-up on outstanding regulatory issues internally (with study Principal Investigators and support mangers) and externally (Clinical research networks, Division of AIDS, Ethics Committees, SAHPRA, local and international regulatory bodies)

Conduct monthly regulatory review of unit studies to ensure compliance, corrective action and preventive action is completed.

Quality Coordination:

 

Integration of regulatory and quality systems to achieve data integrity and participant safety

Co-ordinate Quality Management processes for all clinical components to ensure compliance with protocol, GCP and local and international guidelines

Development, implementation and evaluation of the clinical quality management plan.

Supervise quality of work through site visits, formal quality control processes, review trends from external monitoring reports, and identify areas for re-training and improvement with trial Principal Investigators.

Training:

 

Recruitment, training and mentorship of quality assurance officers including supervisor of the quality assurance team

Coordinating and monitoring of staff training to ensure staff are adequately trained and competent to complete study related procedures.

Maintain a training database for all clinical trial staff and identify individuals who require further training.

Report writing:

 

Prepare, submit and present Regulatory and Quality reports to relevant stakeholders

Contribute to the unit annual report and grant writing processes within the unit

Core Requirements:

 

4-year qualification in Biomedical science or public health or relevant health related discipline

5 years’ experience in Research or Clinical Trials,

3 years Regulatory experience, with submissions to various regulatory authorities,

2 years Quality Assurance experience in Research or Clinical Trials

Experience with Research Protocols and SOPs.

Good Clinical Practice training certificate

Proficient in Microsoft office

Advantageous:

 

Registered for a Master’s degree

Independent, meticulous attention to detail, results-driven individual

A team player with excellent interpersonal and organisational skills

Flexible, adaptable and innovative

Excellent verbal and written communication skills

Valid Code 08 manual Driver’s license

 

Interested candidates can send their CV

Only registered members can apply for jobs.