Medical Officer - Soweto, South Africa - AJ Personnel

AJ Personnel

Verified Company

Soweto, South Africa

1 week ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Additional Information:

- _Wits VIDA Research Unit conducts cutting-edge scientific research_
- _We aim to save lives across Africa and low and middle-income countries through translational research that informs local and global policy recommendations on infectious diseases and the use of next-generation and novel vaccines_
- _Our research is focused on clinical and molecular epidemiology of vaccine-preventable disease, clinical development and evaluation of vaccines, the study of the immunology of vaccines including in people living with HIV, and basic science research aimed at the discovery of potential vaccine epitopes_
- _The pediatric and neonatal surveillance research portfolio includes but is not limited to TB incidence research, viral and bacterial surveillance in infants and young children admitted across various tertiary hospitals across the country_

Main purpose of the job:

To provide medical leadership in support of clinical research activities, including overseeing relevant research streams, providing clinical insight and direction for all aspects of studies (including, for example, screening and enrolment of study participants, oversight of data and clinical research operations)

Location:

-
VIDA

Chris Hani Baragwanath Hospital

Soweto, Johannesburg

Key performance areas:

Clinical Research Direction_
Strategic review and management of clinical trials i.e., devising systems and processes to ensure effective and efficient study conduct in liaison with program and organisation management
Perform studyrelated procedures, blood draws, vaginal and rectal swabs nasopharyngeal aspirates/swabs on infants' young children and adults including pregnant women, and other procedures as required
Project Management_
Plan, implement, and complete the clinical research activities for the clinical trials or studies in accordance with Good Clinical Practice and Standard Operating Procedures
Oversight of the PNS portfolio, ensuring projects are scoped, planned, budgeted, and executed according to protocol guidelines and relevant policies and procedures, with effective resource management and collaboration
Collaborate with investigator/s and design projects in line with protocol requirements
Project planning including timelines, budgets where applicable, deliverables, dependencies, and resource planning
Manage teams and resources required including crossfunctional inputs and teams/staff who may work across projects to effectively drive objectives and efficiency
Implement, document, and track project deliverables and milestones including all administrative requirements
Coordinate and conduct projectrelated training and skills assessments as well as provide site

- or field-specific support in the case of multiple sites and/or fieldwork

Organize and attend or lead meetings, presentations, and calls as required
Drive all regular internal and external report preparation and delivery
Collaborate and liaise effectively with colleagues and other departments towards effective and efficient project planning and delivery
Identify areas for improvement in process flow and project management and collaborate with research leads/senior management to initiate and drive process improvements; take initiative and show ownership
Quality Assurance and Regulatory Oversight_
Assist with creating CRFs and quality assurance of study file source data, i.e., clinical source notes and CRFs
Develop a research management plan in conjunction with PI and oversee and ensure compliance
Ensure ethics and consent processes are followed as per GCP guidelines.
Collaborate with investigator/s on participant recruitment and retention and contribute to community liaison strategies
Develop and maintain unit and projectspecific SOPs
Maintain all site files and review monthly in collaboration with the regulatory department.
Create and drive quality assurance framework for projects and ensure research quality and processes are adequately internally monitored
Perform monitoring and evaluation functions by ensuring that data is collected systematically on specified and agreedupon indicators
Training/escalation for corrective action for site staff based on all applicable monitoring or quality findings
Liaison with the data management to ensure highquality data and database management.
Complete and submit Ethics and Regulatory documents or reports
Track protocol approvals, communications, certifications, translations, insurances, and all study administrative and compliance indicators
Monitor and report critical events and protocol deviations
Appropriately escalate all relevant issues to the required and respective stakeholders
Act as first contact liaison with the Ethics Committee in respect of all projects within your domain and liaise with the research administration and unit regulatory team on required submissions and maintenance
Ensure all administrative task