Medical Officer (Doctors X6 – Evaluation Of Llms 12 Months Ftc Wits Vida)

Ajpersonnel; Gauteng; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading health research institution in Gauteng is seeking an experienced individual to assist with research activities, quality control of clinical data, and project management. The ideal candidate should possess an MBChB / MBBCh Degree and have project management experience. The role involves significant collaboration with various stakeholders and adherence to Good Clinical Practice standards. This position is based at Chris Hani Baragwanath Academic Hospital and offers an opportunity to contribute to vital health research efforts.

Qualifications

• Ability to coordinate study efforts.
• Comfort with the Microsoft Office suite.
• Professional Body Registration with HPCSA.

Responsibilities

• Assist with study activities and data quality controls.
• Manage project budgets, timelines, and deliverables.
• Collaborate with investigators for study requirements.

Skills

Project Management

Clinical Data Collection

Quality Assurance

Stakeholder Management

Microsoft Office Suite

Education

MBChB / MBBCh Degree

GCP Certification

Job description

Background

Background :

The Vaccines and Infectious Diseases Analytics (VIDA) Research Unit of the University of the Witwatersrand, formerly RMPRU (Respiratory and Meningeal Pathogens Research Unit), has conducted numerous studies for over 20 years to assess the burden of and prevent vaccine-pre-ventable diseases (VPD).

Current studies and projects include infant rotavirus and BCG trials.

Main Purpose of the Job

To assist the VALID 2.0 study :

Collection abstraction and quality control of multi-modal clinical data (written notes, imaging, etc.).

Basic facilitation of expert panel discussions.

Quality control of data.

Location

Primarily based at Chris Hani Baragwanath Academic Hospital.

Key Performance Areas

1. Study Research Activities

Strategic review and management of observational studies to devise systems and processes ensuring effective study conduct.

Collect abstract and quality control clinical data as per study requirements in accordance with Good Clinical Practice and Standard Operating Procedures.

2. Project Management

Plan, implement and complete study research activities in accordance with Good Clinical Practice and Standard Operating Procedures.

Oversight of study operations at different sites in collaboration with the Project Manager, ensuring scope, planning, budget, and execution meet protocol guidelines and policies.

Collaborate with investigators and design projects aligned with protocol requirements.

Project planning including timelines, budgets, deliverables, dependencies and resource planning.

Manage teams and resources required, including cross-functional inputs and staff, to drive objectives and efficiency.

Implement documentation and track project deliverables and milestones including all administrative requirements.

Coordinate and conduct project-related training and skills assessments, providing site support where multiple sites are involved.

Organise 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 project planning and delivery.

Identify areas for improvement in process flow and project management, collaborating with research leads and senior management to initiate and drive improvements.

3. Quality Assurance and Regulatory Oversight

Assist with creating CRFs and quality assurance of study file source data (clinical source notes and CRFs).

Develop a research management plan in conjunction with PI and PM, ensuring compliance.

Ensure ethics and consent processes follow GCP guidelines.

Collaborate with investigators on participant recruitment and retention, contributing to community liaison strategies.

Develop and maintain project-specific SOPs.

Maintain the site file and review monthly in collaboration with the regulatory department.

Drive the quality assurance framework for the project and ensure research quality and processes are adequately monitored.

Perform monitoring and evaluation functions by ensuring systematic data collection on specified indicators.

Provide training and escalation for corrective action for site staff based on monitoring or quality findings.

Liaise with data management to ensure high-quality data and database management.

Submit ethics and regulatory documents or reports.

Track protocol approvals, communications, certifications, translations and all study administrative and compliance indicators.

Monitor and report critical events and protocol deviations.

4. Research and Academic Development

Escalate relevant issues to the required stakeholders.

Support the development of long-term health sciences research, including strategic planning and action plans with indicators.

Pursue own research interests consistent with the overall research agenda and in conjunction with research leadership.

Advise on the implementation of large multi-site research and dynamically contribute to new relevant research questions.

Design, write and submit or contribute to new proposals.

Oversee adequate and accurate filing of all study-related files.

Prepare for study closure and archiving.

Conduct data analyses and prepare tables as required.

Create and implement a patient retention strategy (if required).

Develop required checklists (e.g., inclusion / exclusion criteria, randomisation, controls).

Ensure donor compliance including procurement timesheets and sponsor / donor reports.

Provide ad-hoc support to department or functional team leads to meet project targets.

Arrange site visits with donors.

Compile and ensure accurate factual reports to stakeholders.

Liaise with government departments and attend stakeholder meetings as required.

Maintain operational finance records and stock management of the project.

Maintain functionality of unit equipment and facilities through liaison with operations team.

Generate reports on participant recruitment / retention, follow-up, compliance, data management, study deliverables and investigator-required reports.

5. Customer Service and Stakeholder Relations

Build and maintain professional relationships and communicate effectively with internal and external stakeholders.

Train staff and promote knowledge exchange and peer learning.

Manage stakeholder expectations and communicate appropriately with initiative and solutions.

Maintain high-standard internal and external stakeholder relations.

Escalate issues appropriately, ensuring discretion and risk management and problem-solving.

Effectively manage work processes and relationships to maintain productivity.

6. Staff Management

Lead cross-functional teams to promote productivity.

Empower and develop teams or individuals as skills needs are identified.

Foster an environment that promotes talent recognition, development and individual leadership.

Ensure team compliance with policies, unit standards and internal communications, promoting company values.

7. Effective Self-Management and Performance Ownership

Manage staff including accountability, performance, conduct and efficient processes.

Demonstrate effective delegation and decision-making.

Take ownership of tasks and activities, demonstrating self-management.

Maintain high standards of professionalism in presentation and delivery.

Apply knowledge of organisational systems, structures, policies and procedures to achieve results.

Ensure productivity standards are consistently maintained and provide resolution for challenges.

Support and drive the organisation's core values.

Maintain a positive attitude and respond to feedback, managing disruptive emotions and stress.

Take ownership of personal career development.

Required Minimum Education and Training

MBChB / MBBCh Degree.

Ability to coordinate study efforts in collaboration with the Project Manager and abstract clinical information from written notes.

Comfort with the Microsoft Office suite.

GCP Certification.

Professional Body Registration

HPCSA and Medical Protection Society membership.

Required Minimum Work Experience

Previous Research and Internal Medicine experience are desirable.

Desirable Additional Education, Work Experience and Personal Abilities

Experience with research and project management.

Understanding of research environment, regulatory and ethics and Good Clinical Practice; project management skills and usage of relevant tools; quality assurance experience; liaison with external stakeholders at all levels.

Strong networking and relationship-building ability.

Able to draft and review Standard Operating Procedures.

Advanced computer literacy, including basic data presentation and quality assessment.

Conflict management and problem-solving ability.

Attention to detail.

Demands of the Job

Ability to work extended hours.

Ability to handle multiple conflicting deadlines and maintain high productivity.

Deadline-oriented.

Ability to work within the contexts of international regulatory bodies.

Flexibility.

TO APPLY

Only if you meet the minimum job requirements and experience, submit a detailed updated CV.

Please apply online and complete your registration via our website to accept the POPIA terms and conditions.

This will create your permanent profile with which you can apply for all jobs advertised by AJ Personnel.

You may remove your profile from AJ Personnel when you are no longer in the job market.

Applicants who do not meet the criteria will not be considered.

Wits Health Consortium will only respond to shortlisted candidates.

Applications not contacted within two weeks of the closing date may be considered unsuccessful.

Closing date : 04 November

No CV will be accepted after the closing date.

Please Note

WHC will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of

• and subsequent amendments.

AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium.

AJ Personnel does not provide salary or other position information.

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