No more applications are being accepted for this job

Study Coordinator - Soweto, South Africa - AJ Personnel

AJ Personnel

Verified Company

Soweto, South Africa

1 month ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Main purpose of the job:

To administer, maintain and coordinate the logístical 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 protocolspecific forms and studyrelated 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 missionfocused and aligned with our core values
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 Coordinators 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 decisionmaking 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 selfmanagement and performance ownership_
Take ownership and accountability for tasks and demonstrate effective selfmanagement
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 decisionmaking
Able to prioritize own workload, take initiative (proactive) and work to tight deadlines
Selfmotivated 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: