Medicines Control Officer: Clinical Trials Unit

DEPARTMENT OF HEALTH
REF NO: NDOH 58/2017 Chief
Directorate: Food Control, Pharmaceutical Trade and Product Regulation. Directorate: Clinical Evaluation and Trials Unit
SALARY : Grade 2: R615 111 per annum. Registration as a Pharmacist OR B-Pharm degree and a minimum of eight (8) years appropriate experience. Grade 3: R703 314 per annum. Registration as a Pharmacist and a minimum of eight (8) years appropriate experience OR A B-Pharm degree with a minimum of sixteen (16) years appropriate experience. Salary grade will be determined in accordance with the above requirements as per the OSD. Original certified certificates of service must be submitted with your application as well as proof of registration as a Pharmacist.
CENTRE : Pretoria
CLOSING DATE : 11 September 2017

REQUIREMENTS :
Qualification and years of experience required are indicated above.
Knowledge and application of the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965) and related Regulation pertaining to the Act.
Good clinical practices and clinical trials conduct and processes.
Knowledge of safety, efficacy and quality aspects of medicines.
Good planning, organisational, supervisory, communication (written and verbal) and computer skills.
Ability to work independently.
Must be
DUTIES :
Receive clinical trial applications and applicant responses.
Co-ordinate clinical trials activities and committee meetings.
Prepare committee and council documents.
Supervise administrative staff and attend to queries addressed to the Clinical Trials Unit.
Minute Clinical Trial Committee (CTC) proceedings as well as executive Clinical Trial Committee recommendations and Medicines Control Council (MCC) resolutions.
Develop Standard Operating Procedures (SOPs) for conducting clinical trials as well as related.
Policies and guidelines.
Technical screening and allocation of new clinical trial applications.
Review any other clinical trial correspondence.
Liaise with applicants and committee members.
Co-ordinate and keep records of clinical trial related activities.
Attend CTC meetings.
Investigate that may arise from time to time.
Manage risk and audit queries.

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