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) ensures that the clinical trials are always run according to protocol 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:
• Familiarizing themselves with study specific protocols and requirements and stay up to date with amendments.
• Undertaking the informed consent (IC) process by presenting a study to possible participants and/or family members.
• Assisting the investigator in ICF signing process and ensure that adequate time and privacy for reflection and answering questions has been provided. Performing quality checks on ICF (informed consent form).
• Performing the quality checks and completion of study documentation, including source, case report forms (eCRFs) and study logs.
• Educating participants on study related requirements and compliance.
• Planning visit study specific procedures ahead and performing procedures in accordance with protocol requirements following prompts and flow of the relevant source documents; Documenting participant feedback, investigator product compliance and related care and procedures in source documents.
• Familiarizing themselves with normal ranges in vital signs, ECG measurements, and safety blood ranges, to identify abnormalities and act/document accordingly to ensure participant safety.
• Familiarising themselves with special study specific safety reporting requirements.
• Collecting biological specimens (sputum, saliva, blood, etc.), preparing specimens where needed and completing any related documents, logs and checklists accurately and in real time according to GCP specifications.
• 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.
• Providing the clinical and administrative nursing support and oversight whilst creating a safe and participant friendly environment during clinical study conduct.
• Performing miscellaneous job-related duties as assigned.
• Competent in nursing procedures according to registration scope of practice and including, but not limited to, monitoring and recording of vital signs, general wellbeing, ECG measurements, performing phlebotomy, IV preparation, administration and monitoring, medication administration and control as well as resuscitation procedures.
Ideal Requirements
• Nursing diploma or degree (Professional nurse) or Enrolled Nurse.
• Valid Nursing Council registration and certificate (SANC).
• Valid ICH GCP certificate.
• Strong administrative skills.
• Computer and internet competency and basic knowledge of Microsoft Word, Excel, Outlook.
• Practical experience in research and/or clinical trials would take preference.
• Valid Driver’s License
• Flexibility to work at other TASK sites and to accommodate occasional night and weekend schedules.
Key Personal Inherent Characteristics
• Communicating effectively in English (verbal and written).
• Excellent inter-personal skills.
• Good team player, has diplomacy and tact.
• High attention to detail.
• Excellent follow up skills.
• Friendly.
• Planning and working in an organised manner.
• Efficient.
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.
By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act.
