Main purpose of the job:To administer, maintain, and coordinate clinical trials according to good clinical practice, the study protocol, and the site standard operating proceduresAct as a pivotal point of contact for the clinical trial team and the study sponsor(s)Location:32 Princess of Wales Terrace, Parktown/17 Eaton Road/Charlotte Maxeke Johannesburg Academic Hospital/ Chris Hani Baragwanath Academic Hospital, Soweto Key performance areas:Study ManagementPrimary SSC on trial to oversee all operations on trial, ensure protocol and GCP complianceAttend Investigator meetings, SIV, and any other in-person or virtual training to manage the studyAssist study team with efficient study start-up, conduct, and close-outEnsure access to online portals for self and support staffManage regulatory updates throughout the study (New ICFs, Protocol Amendments, etc.)Manage site monitor visits according to GCP and Site SOPProactively resolve protocol queries and missing data with Investigators and Clinical Trials AssistantsCommunicate with CRO, Sponsor, and regulatory authorities regarding notifiable trial eventsParticipant ManagementPrepare for and manage participant visits and data capturing in line with protocol and site SOPsAssist in patient recruitment, screening, and enrolment of eligible patients according to protocol requirementsPerform and/or book procedures correctly per protocol within the scope of practiceManage lab kits and study samples according to protocol, procedures manual, and local legislatureAdminister study medication safely in line with the scope of practiceBe able to manage medical emergencies within the scope of practiceCommunicate well with investigators regarding participant welfare while on studyNotify relevant parties of Serious Adverse Events or Events of Medical Importance within 24 hoursQuality control of patient files and data entries (i.e., eCRFs, CRFs)Teamwork & SupportAssist team members with an open helpful attitude, perform on-the-job training where necessaryAssist the Pharmacist with visit activities (IVRS, IP management, etc.)Assist the administrative staff with arrangements to be made for participant visits (Patient transport with Uber, Vendor booking details, etc.)Assist site finance staff with payments on the study (pass-through, travel fees, etc.)Assist the team with ad hoc assignments and duties as needed, delegated by the line manager, and within the scope of practiceRequired minimum education and training:Professional Nursing Diploma with a Diploma in OncologyRecent Good Clinical Practice (GCP) and IATA Certification requiredRequired minimum work experience:Minimum of 2 years of Oncology experience in a clinical trial environmentProfessional body registration:Registered with the South African Nursing Council (SANC)Desirable additional education, work experience, and personal abilities:Good communication skills both written and verbalThorough with good attention to detailMust be computer proficient to manage online study systemsMust be able to process and ship study-related lab samplesPhlebotomy skills and the ability to perform an ECG are necessaryOrdered and systematic in approach to tasks, with strict compliance to protocolsExceptional organizational and administrative skills are required together with working knowledge of Microsoft OfficeAble to exercise discretion and independent decision-makingAbility to prioritize own workload, take initiative (pro-active), and work to tight deadlinesSelf-motivated with high regard for work ethic, values, and integrityOvertime may and traveling will be required from time to timeLight physical activity is requiredTO 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: 16 April 2024.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.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.
