Research Nurse
1 week ago
**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 Research Nurse(RN) will be responsible for various nursing procedures and patient care. The RN ensures that the clinical trials are run according to protocol and Good Clinical Practice (GCP) requirements, 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 or assisting with the informed consent (IC) process by adhering to the guidelines and requirements of the IC process; performing quality checks on IC form and other study documentation. Assisting the investigator in verifying that the participants’ meet inclusion and exclusion criteria before randomization.
- Preparing participants for study. Educating, caring for, and supporting the study participants throughout the course of the trial
- Assisting the Lead Study Nurse Coordinator / Study Coordinator with scheduling of study participants. Scheduling relevant appointments for study participants. Liaising with City of Cape Town and provincial government clinic staff, as required.
- 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 within given timelines and specified order, with the assistance of pre-drafted source documents; Documenting 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
- Ensuring participants’ safety by ensuring compliance with study procedures. May be required to perform various nursing procedures including but not limited to vital signs, ECG measurements, phlebotomy, IV preparation, administration and monitoring, medication administration and control. Is competent in undertaking resuscitation procedures.
- 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.
- Administering investigational products (medications) orally, intramuscularly and intravenously as per protocol. Keeping IP documentation and logs current and accurately completed. Keeping IP controlled, managed and stored as per protocol and study pharmacist’s instructions. Working with the Lead Study Nurse Coordinator / Study Coordinator and pharmacist in managing IP logs.
- Collaborating with all members of the study team; providing information and resolving queries for data management and Lab. Contributing to study performance objectives and deadlines.
- Performing miscellaneous job-related duties as assigned, e.g., Entering of source data timeously and accurately into electronic or paper-based case report forms (CRFs), sample processing, Investigator Site File (ISF) management, etc.
**Ideal Requirements**
- Nursing degree or diploma (Registered nurse) with experience in clinical trials (Advantageous). Alternatively, an Enrolled Nursing qualification with at least two years’ experience in clinical trials.
- Valid Nursing Council certificate (SANC)
- Valid ICH GCP certificate
- Valid BLS certificate/equivalent (Advantageous)
- Valid HIV Counselling certificate/equivalent (Advantageous)
- Computer literacy - ability to use Word, PowerPoint and Excel at intermediate level.
- Valid Driver’s License (Advantageous)
- Flexibility to work at other TASK sites and to accommodate occasional night and weekend schedules.
**Key Personal 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, Brooklyn, Delft
**Contract Type**:12 Month Fixed Term
**Applications Close**:08 May 2024
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, Temporary
Contract length: 12 months
Application Question(s):
- Do you have an Enrolled Nursing qualification with at least two years' experience in clinical trials?
- Do you have a nursing diploma or degree?
- What is your notice period?
- What are your salary expectations?
Application Deadline: 2024/05/08
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