Essential Requirements:


Certificate in Enrolled Nursing and current registration with the South African Nursing Council (SANC) as an Enrolled Nurse
3 to 5 years’ experience in Clinical research on Multiple projects
Fluency in English, Afrikaans and /or isiXhosa
Excellent interpersonal, communication (both verbal and written) and time management skills.
Proficiency in MS Office (Word, Excel, PowerPoint, and Internet)
Excellent phlebotomy skills
Strong organizational skills
Detail-orientated
Proactive and self-motivated
Ability to work under pressure and in a fast-paced environment
Ability to maintain the integrity of research studies.
Open-minded and always willing to learn
Flexible; able and willing to make changes to work schedule to meet the demands of the company
Willingness to travel to various CLII research sites within Cape Town
Ability to work in a team and independently and to foster a collaborative relationship with local clinics and hospitals
Credit and Criminal Clear


The following will be advantageous:


Interest in Infectious Diseases Research
Knowledge of Good Clinical Practice (GCP) with current GCP certification
Previous experience working with TB patients, especially drug-resistant TB patients.
Valid Driver’s license (advantageous) and own reliable transport
Proficiency in Data Management systems


Responsibilities include (but not limited to):

Participant recruitment, enrolment and retention:


Recruitment of eligible participants for research projects(s)
Administration of informed consent and all study related activities
Providing support and education to participants regarding the study
Assist the coordinator to monitor trial related activities, i.e. enrolment, recruitment and randomization processes
Ensure relevant data is collected from source documentation i.e. copies of Identity documents, birth certificates etc.


Clinical:


Screen participants for inclusion into the study using specified inclusion and exclusion criteria
Scheduling of participants for clinical examination and follow up
Arrange participant transport and arrange and book participants follow up visits and telephone calls.
Ensure that the necessary documents are available and ready for each study visit.
Ensure that results are received and seen by the Investigators and ensure that abnormal results are followed up as requested.
Monitoring trial related activities, before, during and after the trial
Obtain participant specimen samples i.e. perform phlebotomy, collecting urine and saliva
Completing Point of care test i.e. Rapid test for Pregnancy, Retroviral status, other
Coordinate transportation of biomedical samples to the relevant laboratories
Complete laboratory specimen transfer/transport logs.
Administering medications or treatments as per the study protocol and under supervision of the Registered Nurse
Monitoring vital signs (e.g., blood pressure, heart rate, temperature). 


Study Administration, Collection and Management:


Maintain applicable study logs (screening, enrolment, Participant Confidential Identification log, AE tracking, etc.).
Maintain record of all communications as required.
Ensure all study procedures and tests are properly documented in source according to ICH GCP guidelines.
Assist with participant record management
Collecting and documenting data on case report forms (CRFs). 
After trial ensure all data collected and filed away in correct order
Entering data into electronic databases
Performing quality control checks on data to ensure accuracy. 
Assist Coordinator with administrative duties relating to regulatory functions
Maintain accurate records for inventory of clinical stock, equipment, material and supplies


Ad-hoc Duties


Assist with participant reimbursement and petty cash management i.e. submission of receipts, collecting of petty cash etc.
Assist with archiving and any other research-related duties as required