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 with scheduling study participants and liaising with relevant stakeholders, 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 subject safety, protocol compliance and always preventing protocol deviations.Familiarizing themselves with normal ranges in vital signs, ECG measurements, safety blood ranges, to identify abnormalities and act/document accordingly ensuring subject safety.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 relevant team members 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 (TASK Clinical Research Centre primary site).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.Details: Area: Bellville, Cape Town
Contract Type: 12 Months Fixed Term
Applications Close: 20 September 2024
Please indicate in your application that you are applying for the above-mentioned position.
If you have not received a response within one month, your application was most likely unsuccessful.
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.
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