Study Coordinator (Senior) Wits VIDA

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:

• Wits VIDA - Chris Hani Baragwanath Academic Hospital – Soweto, Johannesburg

Key performance areas:

Oversight of clinical trials

• Assist clinical trials manager with oversight of clinical trials in conjunction with investigators and study coordinators
• Provide comprehensive support of all operational aspects of clinical trials including overall delivery of protocol objectives, logistics, visit scheduling including home visits, administration, reporting, and data collection
• Ensure research teams maintain protocol integrity and participant safety throughout the study
• Participate in or support investigators as needed in generating source documents, designing, and review of protocol-specific forms and study-related documents. e. Lead or coordinate staff training interventions related to protocols as required
• Liaison with other departments as required to ensure study deliverables are met and processes effectively

Stakeholder relationships and customer service

• Actively participate in required monthly (or as needed) sponsor meetings, monitor visits, as well as weekly feedback on the project status
• Participate in all phases/components of the research process from initiation to closure (Investigators' meetings, site initiation visits, etc.)
• Support a clinic environment and culture that is mission-focused and aligned with our core values
• Ensure all customer interaction (both internal and external customers) is of the highest professional level, e.g., respond to emails/queries within a reasonable time frame
• Build and maintain authentic relationships with all stakeholders ensuring that all interactions are professional
• Establish and maintain a relationship of trust and respect with participants, sponsors, CROs, and other stakeholders

Clinic operations management

• Review the status of monitors’ reports of applicable projects with Project Teams and address issues appropriate. Provide leadership to junior study coordinators
• Create and maintain channels of regular communication with the respective study PIs/Managers/Study Co-ordinators and the Executive Director
• Enforce standard policies and procedures of VIDA in all operations as well as Ethical guidelines and principles of Good Clinical Practice and ensure compliance
• Identify quality improvement areas in each project and ensure appropriate strategy and quality improvement initiatives are developed and measured
• Delegate decision-making authority, tasks, and responsibility to appropriate persons to maximize organization and employee effectiveness
• Manage the essential documents as required by local regulations and ICH GCP before, during, and after a clinical trial like training logs, delegation logs, enrolment- and screening logs
• Assist clinical trials manager with resource planning and management
• Assist clinical trials operations manager with oversight of departmental administration including adequate maintenance and availability of all supplies and equipment

Effective self-management and performance ownership

• 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 of driving your own career development by participating in ongoing training and
• development activities such as workshops, forums, conferences, etc.
• Participate and give input in ad hoc projects and initiatives
• Mentor junior study coordinators to ensure a high standard of quality is maintained

Required minimum education and training:

• 3-year Diploma or Degree in Nursing or Health Sciences

Required minimum work experience:

• Minimum 5 years experience in a clinical trials environment

Professional Body registration:

• South African National Council (as applicable)

Desirable additional education, work experience, and personal abilities:

• Demonstrable experience with training, quality assurance, regulatory affairs, trial management, and CRO liaison
• 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 patient's needs and requirements
• Ability to multitask

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: 02 December 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.

Please note:

• Our Client, WHC – VIDA, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.
• WHC, in accordance with its 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.
• AJ Personnel is only responsible for advertising the advertisement on behalf of their client Wits Health Consortium.
• AJ Personnel does not have any salary or other information regarding the position.