Job Description

Main purpose of the job:

• Under direct supervision of the site principal investigator(s), to lead the clinical trial site(s) team, manage day-to-day activities of the trial site(s), and provide health care to patients participating in the EFFECT clinical trial (Mycology Unit) according to the study protocol
• The applicant will have the opportunity to work in a dynamic, international, and supportive research environment and to shape the conduct of this large multi-center clinical trial
• They will also be expected to contribute to the data analysis and any peer-reviewed publications arising from the study and to contribute to related sub-studies or projects

Location:

• Livingstone Hospital and Dora Nginza Hospital, Gqeberha (Port Elizabeth)

Key performance areas:

Clinical trial management

• Contribute to the development of study documentation including trial protocols, patient information sheets and consent forms, SOPs/ WPDs, quality assurance and quality control guidelines, and training manuals
• Undertake recruitment of eligible patients according to protocol requirements
• Maintain close contact with the trial management group and consult them on strategic issues that might have any safety or major financial implications for the project. This will include, but not be limited to, collation of weekly reports of study progress to be shared with the trial management group and funders, and detailed reports for the Data Monitoring Committee and Trial Steering Committee
• Conduct clinical trials in accordance with GCP regulations and standard operating procedures
• Proactively resolve protocol queries and missing data with the Trial Management Group

Patient Care and Screening

• Assist in all clinical aspects of the study, including venepuncture, cannulation, blood sample processing, drug administration, and clinical observation when necessary ensuring that they are carried out within the Hospitalxe2x80x99s and Sponsorxe2x80x99s policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) Data Protection Act and Human Tissue Act

Quality Assurance

• Monitor and evaluate the quality of care and counseling conducted at the study site(s) and assess findings with the team
• Perform spot-check evaluations to quality control clinical source notes and CRFs
• Monitor the Study Recruitment/Retention Plan including planning meetings to address challenges of study enrolment and participant retention
• Conduct regular site team meetings to identify, discuss, and solve study queries
• Meet with Trial Monitors as and when required

Staff Management

• Play a supervisory role for the study clinical and nursing teams to ensure that; teams adhere to the set standard operating procedures in the conduct of clinical trials and that all staff are fully trained in the SOPs pertaining to their daily work; data collection process is enhanced for quality with quality control measures in place; recruitment/accrual targets are being met; proper source documentation procedures are followed

Required minimum education and training:

• MBBCh Degree

Required minimum work experience:

• Minimum 1-year work experience, preferably in a clinical research environment

Desirable additional education, work experience, and personal abilities:

• Certification in Good Clinical Practice (GCP)
• Project management qualification will be an advantage
• Thorough, with good attention to detail
• Ordered and systematic in approach to tasks, with strict adherence to protocol
• Exceptional planning and organizational skills are required together with working knowledge of Microsoft Office
• Able to exercise discretion and independent decision-making
• Ability to prioritize own workload, take initiative (pro-active), and work to tight deadlines

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: 27 September 2023.
• 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.

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