|Location||Durban, Durban, South Africa|
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.
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.
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.
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.
Prepare, submit and present Regulatory and Quality reports to relevant stakeholders
Contribute to the unit annual report and grant writing processes within the unit
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
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