Study Coordinators (Nurses) x 2 (Wits RHI)

Main purpose of the job:

• To administer, maintain and coordinate the logistical aspects of clinical trials according to good clinical practice, the study protocol, and the standard operating procedures and to act as a pivotal point of contact for the clinical trial team and the donors

Location:

• Shandukani Research Centre, Wits RHI, Hillbrow - Johannesburg

Key performance areas:

• Assist and oversee participant recruitment, screening, and enrolment of eligible participants according to protocol requirements
• Maintain screening and enrolment logs on SharePoint /One drive and failure documentation
• Inform participants about the study
• Liaise with sponsors to ensure CRFs and laboratory kits are prepared
• Provide background information to participants prior to informed consent being signed
• Book and/or perform study-specific pre-screening procedures and perform eligibility enrolment checklist as required
• Conduct Informed Consent Process according to GCP, study protocol, and site SOPs
• Oversee and support retention of participants (scheduling of visits, contact of participants, follow up of missed visits)
• Conduct pre and post-HIV Counselling (if needed)
• Do direct data entry if required and specified as per delegation log
• Adherence to all protocols
• Manage scheduled and unscheduled participant visits and appointments in accordance with the study protocol and record it in the research calendar and visit log
• Preparation of participant study (scheduled and unscheduled) visits
• Update and maintain participant files
• Perform participant vitals (as and when required)
• Assist with performing electrocardiograms, collect sputum and urine
• Assist with the drawing of blood samples in infants and perform phlebotomy in older children and adults
• Assist with the collection, processing, storage, and shipment of specimens
• Involved in reporting any adverse events within required time frames
• Complete relevant questionnaires and assessments
• Provide appropriate health education and counseling where necessary
• CRF data entry and direct data entry
• Ensure that labs are printed, converted, graded, and reviewed by an investigator prior to CRF completion, according to SOPs; and complete DCFs as required
• Maintain an inventory of laboratory samples
• Liaise with protocol team and various stakeholders, as required
• Attend conference calls and training, as required
• Ensure the Emergency trolley is appropriately stocked
• Take responsibility for the Emergency Research Cell phone (and related duties) during allocated time periods and manage calls, SMS, and data usage
• Attending research and clinical team meetings and updating the research meeting minutes for own studies on a weekly basis within the required timeframes
• Review initial Informed consent and translations
• Complete the MTA, send to legal (WHC) and receive labs for review before finalization and thereafter apply for export permits
• Perform quality control procedures on source docs, CRFs, and other study documents as well as direct data entered on the database and perform real-time QC
• Assist proactively with resolving queries from QC, DMC/EDC/eData, QA and monitors
• Maintaining QC reports
• Prepare files for monitoring visits, audits, inspections and meet with relevant external stakeholders
• Involved in compiling and reporting of Notes to File, Protocol Deviations as well as corrective and preventative actions
• Ensure that preventative actions set out in CAPA documents are strictly followed and implemented
• Supervise and manage the duties of subordinates
• Perform and facilitate performance development and assessment through individual coaching and another support mechanism
• Timekeeping and leave proactively managed
• Take ownership and accountability for tasks and demonstrate effective self-management
• Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
• Maintain a positive attitude and respond openly to feedback
• Take ownership for driving own career development in attending training and development sessions and relevant meetings
• Prepare for, arrange and conduct protocol training as required for new and old staff (e.g new protocols, protocol refreshers)

Required minimum education and training:

• Relevant Nursing Diploma or equivalent (3 years)

Required minimum work experience:

• Minimum 2-4 years experience in clinical trials environment

Desirable additional education, work experience, and personal abilities:

• Certification in good clinical practice (GCP) and HIV management
• Experience in phlebotomy and project management
• Working experience in a medical research environment
• Thorough with good attention to detail
• Ordered and systematic in approach to tasks, with strict compliance to protocols
• Exceptional organizational and administrative skills with working knowledge of Microsoft Office
• Able to exercise discretion and independent decision-making
• Able to prioritize own workload, take initiative (pro-active) and work to tight deadlines
• Self-motivated with high regard for work ethic, values, and integrity
• Display concern for patients and willingness to respond to patients’ needs and requirements

TO APPLY:

• Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
• Please Apply Online and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate to accept the new POPIA terms and conditions. This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL. However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market.
• AJ Personnel is fully POPIA Compliant.
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
• The closing date for all applications: 18 January 2022.
• Wits Health Consortium will only respond to shortlisted candidates.
• Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.
• Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
• PLEASE NOTE: Our Client, WHC - RHI, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.

Please note:

• AJ Personnel is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
• AJ Personnel does not have any salary or other information regarding the position.