Requirements

• Nursing Diploma or Degree with South African Nursing Council (SANC) registration as a Registered Nurse
• Minimum of 2 years’ experience in a clinical trials unit
• Fluency in English and isiXhosa
• Computer literacy with sound knowledge of email, Microsoft office suit
• Strong verbal, written and interpersonal communication skills
• Ability to work well under pressure and to maintain effectiveness during changing conditions
• Client focused
• Administration skills
• Must be able to work in a team and independently
• Must be detail orientated
• Willingness to travel and work irregular hours, including weekends from time to time

Advantageous:

• Experience in HIV and Infectious Disease
• Current GCP Certificate
• Sexual Reproductive Health Certificate including implant insertion and removal Certificate

Responsibilities:

Clinical Duties:

• Clinically assess and manage the health of participants as a Research Nurse, within scope of practice, according to protocol requirements, site-specific SOPs and processes, GCP, UCT HREC and SAHPRA guidelines and standards.
• Consult with the safety medical officer/clinical lead/PI and other research staff when necessary.
• Monitor clinical and study procedures undertaken by other healthcare workers (eg counsellors) when necessary.
• Administer medications and investigational products appropriately, as required.
• Refer participants to other clinical care as required.

Protocol-specific procedures

• Ensure all research activities are performed according to the study protocol, site-specific SOPs, SA GCP, UCT HREC, SAHPRA and other relevant legislation.
• Assist with the recruitment, screening and enrolment of participants as per protocol-specific inclusion/exclusion requirements
• Manage participants with Adverse Events (including SAEs) as per protocol requirements, supported by safety medical officer
• Perform other protocol specific procedures when necessary eg: (collection of swabs, counselling, contraceptive implants, STI testing, etc)
• Interpret and act on laboratory results, supported by safety medical officer and investigators
• Attend clinical, protocol and research meetings as required.

Study Administration

• Record and capture all findings in real time, ensuring accuracy and compliance with study
• Document all procedures and investigations timeously, as per project and study requirements – including real time data entry on electronic medical record systems.
• Ensure quality control of all study documentation, including self and peer QC.
• Assist with the design and enactment of standard operating procedures for clinical management and research projects