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 three core values: being pioneering, striving for excellence and working collaboratively.
Individuals are invited to submit applications in response to the following position:
Regulatory & Quality Coordinator
HIV Prevention Research Unit (HPRU)
One - Year Contract
A committed, motivated, suitably qualified and experienced Regulatory/Quality coordinator is required to work with the Principal Investigator/Support Managers and Clinical Site Research Leaders in coordinating regulatory and quality aspects of HIV prevention trials.
- Implementation of systems to ensure regulatory compliance, to local and international guidelines and polices
- Co-ordination of all regulatory activities for all studies conducted at the HPRU
- To prepare new protocol submissions for ethical and regulatory approvals.
- To prepare and submit progress reports to Medicines Control Council (MCC) and recertification with Ethics Committees
- 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, MCC, local and international regulatory)
- 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 and local and international guidelines
- Development, implementation and evaluation of the clinical quality management plan.
- Supervise quality of work through sites 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
- Co-ordinating and monitoring of staff training to ensure staff are adequately trained and competent to complete study related procedures.
- Training, supervision and mentorship of teams.
- Maintain a training database for all clinical trial staff and identify individuals who require further training.
- 4-year qualification in the medical/scientific field.
- 5 years’ experience in research.
- 3-4 years’ experience in regulatory/quality compliance
- Strong regulatory knowledge including GCP and HSP
- Proficient in Microsoft office
- Valid GCP and HSP Certificate
- A Masters degree
- Detailed knowledge of regulatory policies, systems and requirements
- Independent, meticulous attention to detail, results-driven individual
- Excellent verbal and written communication skills
- Valid Code 08 manual Driver’s license
- Independent work with minimum supervision
- A team player with excellent interpersonal and organisational skills
- Flexible, adaptable and innovative
A salary in the region of R304 000.00 per annum, cost-to-company, will be negotiated in consideration of experience and qualifications.
In accordance with the SAMRC’s Employment Equity Plan, preference will be given to suitably qualified candidates from the designated groups. For this reason, we require race, gender and disability status to be specified.
PLEASE QUOTE THE REFERENCE NUMBER (R122A) IN ALL COMMUNICATIONS.
The SAMRC retains the right not to make an appointment.
Closing date: 15 November 2017
Should no feedback be received within 30 days of the closing date,
kindly consider your application as unsuccessful.
Please go to the following Web Site to complete an online application. https://goo.gl/forms/HIaKYneLoqN4Shpt1