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Study Nurse Coordinator

4 months ago

Cape Town, South Africa TASK Full time

**Overall Purpose of the Position**:
The purpose of this role is to perform procedures following the visit schedule as stipulated in each protocol and monitor the health and safety of the participants, and document the response to an intervention, which is typically new drug or therapy in the source documents. The Study Nurse Coordinator (SNC) will be responsible for specialized nursing activities such as phlebotomy, taking of vital signs, symptoms procedures, ECG measurement, administering oral and IV medications, injections, cannulation, and holistic patient care. The Study Nurse Coordinator ensures that the clinical trials are run according to protocol and Good Clinical Practice (GCP) requirements at all times ensuring all procedures are documented in source and data is accurately transcribed onto clinical research forms (CRF) or electronic-CRF’s.

**Key Performance Areas (KPAs) & Responsibilities include, but not limited to**:

- Undertaking of the informed consent (IC) process by presenting a study to possible participants and/or family members.
- Preparing participants for study. Educating, caring for and supporting the study participants throughout the course of the trial
- Assisting the investigator in signing of the IC document and ensuring that adequate time and privacy for reflection and answering questions has been provided. Performing quality checks on ICF (informed consent form)
- Assisting the lead study nurse/nursing manager with scheduling of study participants. Making relevant appointments for study participants, liaising with City of Cape Town and provincial government clinic staff
- Assisting the investigator in verifying whether all in
- and exclusion criteria are met before randomization.
- Planning ahead and performing study specific procedures in a protocol-correct manner and within given timelines and in specified order, with the assistance of pre-drafted source documents; Document patient care and procedures in pre-drafted source documents.
- Completing source documents, logs and checklists accurately and in real time according to GCP specifications. Reviewing source documents for accuracy and completeness
- Collecting biological specimens (sputum, saliva, blood, etc.), preparing specimens and completing any related documents, logs and checklists accurately and in real time according to GCP specifications.
- Documenting procedure actual times and results directly and accurately in source documents
- Administering Investigational Product (IP) as per protocol and keeping the IP administration log up to date and verifying storage are within allowed range as per protocol.
- Entering of source data timeously and accurately into electronic or paper-based case report forms (CRFs)
- Performing miscellaneous job-related duties as assigned
- Being competent in professional registered nursing procedures including, but not limited to, vital signs, ECG measurements, phlebotomy, IV preparation, administration and monitoring, medication administration and control as well as resuscitation procedures.

**Ideal Requirements**
- Nursing degree or diploma (Registered nurse)
- Valid Nursing Council certificate (SANC)
- Valid ICH GCP certificate
- Valid BLS certificate/equivalent would be advantageous.
- Valid HIV Counselling certificate/equivalent would be advantageous.
- Previous experience in Clinical trials (Advantageous)
- Computer literacy - ability to use Word, PowerPoint and Excel at intermediate level.
- Valid Driver’s License
- Flexibility to work at other TASK sites and to accommodate occasional night and weekend schedules (TCRC Primary site)

**Key Person4al Inherent Characteristics**
- Excellent verbal and written communication skills
- Excellent inter-personal skills
- High attention to detail
- Excellent follow up skills.
- Friendly
- Planning and organising skills.
- Efficient
- Has initiative and is proactive.

Area: Bellville, Cape Town

Contract Type: Permanent

Applications Close:29 May 2023
- TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process._
- Meeting our employment equity goals will be acknowledged during the recruitment process._

**Job Types**: Full-time, Permanent

Application Deadline: 2023/05/29