Senior Research Nurse Coordinator

SUMMARY:
The Centre for Lung Infection and Immunity (CLII) (http://www.lunginstitute.co.za), has a number of new and exciting studies starting and require applications for a Senior RESEARCH NURSE Coordinator*.
 
CLII is based within the Division of Pulmonology in the Department of Medicine at UCT and is committed to the pursuit of excellence in research, treatment, training and prevention of TB and COVID-19 in Southern Africa.  CLII conducts various HIV, TB, and COVID-19-related research projects at numerous sites in Cape Town.
 
The successful applicant will be responsible to provide overall coordination of day-to-day clinical trial activities at the UCT Lung Institute and be responsible for strategically leading the clinical trial team (enrolled nurses, community health workers and drivers) to ensure that all clinical trial objectives are achieved timeously and to a high standard. The role includes the supervision and development of training material and training of staff, allocated in clinical research studies; the collection, documentation and, coordination of clinical research data, quality assurance in compliance with Good Clinical Practice (GCP) and project-related/unit and institutional related Standard Operating Procedures (SOPs).

POSITION INFO:
Essential Requirements:

• Nursing Diploma or Degree and current registration with the South African Nursing Council (SANC) as a Registered Nurse
• 5 years’ experience in nursing post registration
• Previous Research experience / minimum 5 years’ experience in coordinating research projects or clinical trial/multi-site projects
• Knowledge of Good Clinical Practice (GCP) with current GCP certification
• Previous experience working within a large research team, preferably within a higher education environment
• Protocol implementation and management
• Ability to coach and mentor staff
• Ability to work under pressure and in a fast-paced environment
• Ability to maintain the integrity of research studies
• Excellent interpersonal, communication (both verbal and written) and time management skills
• Ability to work independently and within a team and to foster a collaborative relationship with local clinics and hospitals
• Fluency in English, Afrikaans and /or isiXhosa
• Proficiency in MS Office (Word, Excel, PowerPoint, and Internet)
• Willingness to travel to various CLII research sites within Cape Town
• Credit and Criminal Clear

• Post Basic Nursing Qualification
• Interest in Infectious Diseases Research
• Previous experience working with TB patients, especially drug-resistant TB patients
• Valid Driver’s license (advantageous)
• Own reliable transport
• Proficiency in Data Management system

• Oversee and ensure that effective recruitment strategies of eligible participants for research projects(s) are implemented and monitored
• Conduct and supervise participant enrolment, collection of informed consent from participants and their parents / legal guardians, information from participant folders, interviews, questionnaires and other sources in line with Good Clinical Practice
• Communication with all relevant study team members (PI’s / Clinical Leads, Senior Managers, QC) to ensure study related approvals are up to date; and with sponsor to report AE’s, SAE’s SUSAR’s, etc.
• Establish, maintain contact with key stakeholders and visit research sites as part of coordinating team
• Assist in compiling and monitoring trial-related reports (recruitment / screening rates and strategies, quality logs and trackers), meeting agendas and minutes.

• Supervision of allocated staff to the clinical trial pavilion i.e. enrolled nurses, community health workers, and drivers.
• Ensure all staff allocated to the clinical trial pavilion is qualified and trained specifically to the various clinical trial protocols.
• Assist the Research Nurse Manager to track attendance, leave requests, logging, recording of absenteeism on the online staff portal timeously and accurately Study Administration:
• Maintain record of all communications as required.

• Coordinate all participant visits for clinical examination and follow up, specific to the protocol.
• Oversee and ensure that all study-related clinical requirements are collected / completed on participants (and recorded) i.e. collection of medical history, phlebotomy, clinical assessments routine BP, urine analysis, performance of ECG’s to determine eligibility, and coordinate transportation of participant specimen samples to the laboratories
• Assisting with pre and post counselling for research participants
• Ensure that recruitment staff are adequately trained to explain study procedures to potential participants
• Ensure research nursing standards and participant care meet good clinical practice standards and requirements

• Oversee/administer all data collection activities (completion of Informed Consent, Case Report Form’s) as per specified protocol,
• Verifying data validity - ensure the completion of all study related documentation/source documents as per protocol and GCP guidelines
• Work closely with the Quality Control and the Data team to ensure all data queries is resolved within the required timeline.
• Assess record management i.e. monitor the flow of participant files.
• Ensure that all relevant participant results are printed and filed
• Assist with archiving study records when required

• Oversee and coordinate the process of coordinating participant reimbursement (petty cash) for the relevant study
• Assist Manager, to identify development needs of staff, and the available training, coordinating training activities.
• Assist Manager to maintain inventory of material and supplies and order new supplies when required
• Coordinate / schedule and attend regular team and unit meetings.
• Perform other research-related duties as assigned.

• Position will be based in Mowbray
• 12-month Fixed Term Contract
• Working hours: 40 hours per week, Monday to Friday