Study Coordinator - Soweto, South Africa - AJ Personnel

AJ Personnel

Verified Company

Soweto, South Africa

2 weeks ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Main purpose of the job:

To administer, maintain and coordinate the logístical aspects of the Group B streptococcus Study according to good clinical practice, the study protocol, and the standard operating procedures
To act as a pivotal point of contact for the GBS team and the donors

Location:

-
Wits VIDA

Chris Hani Baragwanath Academic Hospital

Soweto, Johannesburg

Key performance areas:

Coordinating studyspecific scheduled visits, patient recruitment, and prescreening _
Oversee studyspecific patient recruitment, prescreening, screening, enrolment, and scheduled visits of eligible patients according to protocol requirements
Oversee missed and pending visits and arrange home visits when applicable
Identify obstacles in the screening and prescreening process
Oversee the general conduct of the trial visit procedures according to the study protocol and identify areas of concern
Conduct studyspecific training as required
Oversee adequate studyspecific files

- and record maintenance

Oversee maintenance of adequate studyspecific records including paper logs and electronic logs
Oversee management and printing of uptodate versions of study source documents
Report any adverse events within the required time frames
Interact with study participants as required in terms of compliance and protocol adherence
Perform relevant study administration i.e., checking laboratory invoices weekly
Oversee relevant trial stock management and ensure adequate stock levels are always maintained and expired stock is sent for destruction timeously
Trialspecific quality assurance, regulatory and data oversight _
Ensure all study activities are conducted according to a high standard of quality
Oversee resolution of any CRF, QC, and data queries
Oversee adequate file preparation for monitoring visits in collaboration with the QA team
Collaborate with CRAs as and when required
Oversee timeous query resolution in collaboration with data and operational teams
Oversee adequate maintenance of clinical trial logs and visit statistics
Keeping meeting minutes for internal fortnightly clinic trials meetings
Assist with submission of all new staff to WHREC and CRO, in collaboration with the ethics and regulatory team, and follow up on approvals and appropriate subsequent training and delegation
Assist with collating and submission of SAHPRA/WHREC safety and progress reports and other relevant correspondence
Assist with Investigator Site File overview and maintenance
Assist with studyspecific audit preparation
Staff Supervision _
Ensure that necessary performance management of all employees (relevant RA's and CTA's) are done timeously. i.e., Probationary appraisals, onetoones, performance reviews, etc.
Attend to all staffing requirements and administration i.e. time sheets, leave forms, etc.
Supervise and manage the duties of subordinates daily by being involved on the floor
Identifying staff training needs and being involved with addressing these needs under senior supervision
Assist the team with ad hoc assignments and duties
Stakeholder Relationships _
Actively participate in required monthly (or as needed) sponsor meetings, monitor visits, as well as weekly feedback on the project status
Participant interaction, daily ediary compliance as required, and followup on reports. Outcomes are to be communicated to the study monitor
Participate in all phases/components of the research process from initiation to closure (Investigators' meetings, site initiation visits, etc.)
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

Required minimum education and training:

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

Required minimum work experience:

-
Minimum 2 years experience in clinical trials environment

Professional Body registration:

South African National Council (as applicable)

Desirable additional education, work experience, and personal abilities:

Certification in good clinical practice (GCP)
Working experience in a medical research environment
Thorough with good attention to detail. systematic, with strict compliance with 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

- Self-