Study Coordinator (Prof Nurse)

Study Coordinator (Prof Nurse)
Company:

Aj Personnel


Study Coordinator (Prof Nurse)

Details of the offer

Medical, Gauteng SowetoRNEG - RNEG
A Study Coordinator position is available at our client, Wits Health Consortium's Perinatal HIV Research Unit (PHRU) in Soweto, Johannesburg.
Background
The Perinatal HIV Research Unit (PHRU) was established in 1996. The Perinatal HIV Research Unit has been involved in research, training, policy formation and advocacy in issues concerning HIV-positive women and their children.
In recent years the work of the unit has expanded beyond the original focus of mother-to-child transmission of HIV, to include treatment trials in adults and children, prevention research, psychosocial research and policy development. In addition the Unit has developed an HIV vaccine clinical trials unit (HVCTU) and started with HIV Vaccine Trials back in 2001.
The unit is recognised nationally and internationally as a leader in the field of research and policy in the area of mother-to-child transmission of HIV. It has also developed a reputation as a leading African research unit for clinical trials in adult and children with HIV, with one of the largest cohorts.
Main purpose of the job

To administer, maintain and coordinate the day-to-day logistical and regulatory aspects of vaccine studies according to Good Clinical Practice, study Protocol and Standard Operating Procedures and to act as a pivotal point of contact for the clinical trial team and the sponsor.

Location

PHRU - Kliptown, Soweto, Johannesburg

Key performance areas

Maintain investigation site files/regulatory binders
Ensuring filing is up to date at all time” This will be a key function
Assist the Principal Investigators, Medical Officers and Study team in the day-to-day running of the study and manage clinic flow
Create, update and amend source documents
Prepare for new protocols following the protocol preparation checklist to ensure smooth run of the protocol and liaise with laboratory to receive protocol specific requisition forms, chain of custody forms and the appropriate study kits.
Conduct MOP, protocol, SSP, SOP and other job training for staff as required
Liaise with the sponsor and regulatory organisations for the reporting protocol events and protocol deviations
Assist the principal investigator and quality department to prepare for monitoring visits.
Oversee monitoring visits and ensure all corrections are completed prior to completion of the visit.
Collate staff documents for reg submission, and submission of the essential documents to the relevant IRB/EC.
Ensure that pharmacy have updated regulatory documents.
Compiling study progress reports
Oversee study closure and archiving when applicable
Financial oversight and facilities:
Reconcile participant reimbursement compliance
Reconcile laboratory invoices
Oversee facilities and equipment and liaise with procurement-operations department to ensure facilities and equipment are kept in optimal condition at all times.
Completion of Source Documentation and Case Report Forms
Complete relevant research questionnaires and assessments
QC/QA of participant files

Required minimum education and training

Qualified as Professional Nurse
Registered with the South African Nursing Council
2 years’ experience in a clinical research environment

Desirable additional education, work experience and personal abilities

Current good clinical practice (GCP) certification
Research experience, especially with vaccine clinical trials
Attention to detail
Ability to work under pressure
The ability to speak local languages
Able to exercise discretion and independent decision making
Excellent problem-solving ability

TO APPLY
Only if you do meet the minimum job requirements and experienceas mentioned above, you may submit a detailed updated CV -Please Apply Online
Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
The closing date for all applications is29 July 2020.
Wits Health Consortium will only respond to shortlisted candidates.
Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.
In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.

Please note that 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
Other Benefits:Medical Aid and Provident Fund

Ad Visible Until:29 July 2020
Ref:JHB002446/EvdM
Vacancy Type:Permanent


Source: World_Jobnos


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