Job Description

Main purpose of the job:

• A study coordinator is responsible for coordinating all the trial activities that result in the smooth running of assigned clinical research projects

Location:

• Jose Pearson TB Hospital, Gqeberha (Port Elizabeth)

Key performance areas:

• Identify participants
• Educating participants/family members on protocol and protocol requirements
• Scheduling/booking patients
• Collecting medical history data from participants and hospital records
• Compilation of research documentation
• Informed consent process
• Ensure that all study procedures are fulfilled
• Allocate screening patient identification number
• Assessing inclusion and excluding criteria about protocol requirements
• Randomization
• Educating ward sisters and patients on IMP dosing
• Perform vital data checks and ECGS
• Management of scheduled and unscheduled visits and care
• Print and review results, sign, and grade as necessary
• Follow up on participants with adverse events or abnormal results and inform the investigator timeously
• Follow-up of participants with missed visits
• Countercheck the patients IMP with the pharmacist
• Liaise with Study Monitors during onsite or off-site meetings
• Collect, prepare, and transfer laboratory samples
• Processing of samples and maintenance of harvesting logs
• Maintenance of equipment for sample storage
• Shipment of samples
• Kit ordering and storage
• Ensure that data is eligible, attributable, and of good quality
• Design source documentation in conjunction with Data Management and Principal Investigators
• Maintenance of source documentation in the master file, including version control
• Peer review of all data before data entry
• Enter eCRF data within protocol-required timelines
• Following up on data queries and corrections within a specified time frame
• Maintenance of documentation for the Investigator Site Files
• Preparation of source documentation and Investigator Site Files before audits
• Continuous updating of screening/enrolment logs
• Creation and updates of attendance registers, agendas, training logs, etc.
• Updating of progress reports
• Reporting of SAE/EAE within required timelines
• Reporting of protocol violations and deviations and compilation of CAPAs
• Participant reimbursement per unit SOP
• Book participants' appointments in the diary and remind them of their appointments telephonically
• Ordering of unit stationery as necessary
• Attend team calls for studies as required
• Manage calibration of unit equipment as required (part of the team)
• Maintenance of emergency trolley per requirements (part of the team)
• Actively participate in required monthly (or as needed) sponsor meetings, providing feedback on the Project Status
• Prepare presentations for sponsors and other stakeholders as requested
• Participate in all phases/components of the research process from initiation to closure
• Ensure compliance with infection control requirements
• Provide necessary training to new staff members as delegated by the CRS Leader
• 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
• Take ownership of driving your own career development by participating in ongoing training and development activities such as workshops, forums, and conferences
• Actively and consistently maintain high standards of professionalism in all aspects of personal presentation and delivery as well as a positive attitude
• Apply knowledge of the organizational systems, structures policies, and procedures to achieve results
• Follow through to ensure that productivity standards are consistently and accurately maintained

Required minimum education and training:

• Diploma/Bachelors Degree/Medical Training background
• SANC or another professional body

Required minimum work experience and abilities:

• 2 years of work experience in the clinical research field
• Computer Literacy and proficiency in Microsoft Office packages (Word, Excel, Outlook)
• Individual must have attention to detail, leadership and interpersonal skills, accountability and the ability to work under pressure to adhere to strict timelines is of major importance
• Maintenance of confidentiality will be required

Desirable additional education, work experience, and abilities:

• Experience in Project Management will be an advantage

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.
• 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: 25 March 2024.
• Note AJ Personnel is fully POPI compliant.
• 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:

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

AJ Personnel