Introduction

The Malawi – Liverpool – Wellcome – Programme (MLW) is a world-class health research institution committed to improving health through research, capacity building, and strong partnerships.

Job Summary:

Organize CRSU training, manage documentation, and coordinate with the MLW Training Committee.

Update the training database and remind staff about mandatory courses (GCP, HSP, IC PROCESS).

Assist the RGA in submitting research documents for approvals and reports.

Maintain key documents and communicate with researchers, departments, and the science communication team.

Monitor research studies.

Responsibilities

Key Responsibilities:

Submissions

Centralised coordination of initial and follow-up SAE reporting to ethical and regulatory authorities. Preparation of summary SAE reports for quarterly submission or as requested by authorities.

Assisting the RGA in screening and submitting documents for ethical and regulatory approvals.

Maintaining documentation related to ethical and regulatory bodies.

Making sure progress reports are submitted by researchers in time for ethics and regulatory renewals.

Setting reminders for progress report deadlines on all studies following initial ethical approval and progress report approval.

Tracking responses from ethics committees and regulatory agencies.

Documentation

Creating and maintaining checklists and SOPs

Compiling printing records for project billing purposes

Generating monthly work plans and activity reports

Managing the MLW document control system and coordinating with departmental document controllers across MLW.

Updating the submissions database for ethics and regulatory matters.

Organising ethics study documents chronologically in the RG folder for every study.

Ensuring monitoring reports are distributed within specified timelines.

Research Project Management

Promoting best practices by offering advice and guidance on research governance, including induction for new staff/PIs and managing GCP training records

Arranging and delivering training sessions for MLW staff

Monitoring compliance of MLW research projects

Quality Assurance and Monitoring:

Design and implement QA methods and procedures for research work.

Carry out regular internal checks/audits and quality assurance reviews to ensure adherence to regulations and protocols

Assess and review research paperwork, such as consent forms, case report forms, and data gathering instruments

Training and Capacity Building:

Coordinate and conduct training programs based on the CRSU calendar and specific study needs.

Create training resources and hold refresher courses to address emerging quality issues.

Produce and distribute training certificates to participants.

General

Represent the RGA whenever needed.

Foster effective communication and working relationships with both internal teams and external partners and collaborators.

Qualifications:

BSC in laboratory sciences, nursing, Clinical Medicine, pharmacy or related field.

Remuneration and Benefits

MLW offers an attractive remuneration package that includes a competitive salary package commensurate with the position, a medical aid scheme,

MLW also offers opportunities such as scholarships, upgrading, and training opportunities to employees. These are based on excellent job performance and other set criteria.

MLW recognizes its responsibility to safeguard and protect communities, research participants, and patients. Please note that successful candidates will be requested to undergo a safeguarding check prior to appointment and at regular time points during employment.

• Centralised coordination of initial and follow-up SAE reporting to ethical and regulatory authorities. Preparation of summary SAE reports for quarterly submission or as requested by authorities.
• Assisting the RGA in screening and submitting documents for ethical and regulatory approvals.
• Maintaining documentation related to ethical and regulatory bodies.
• Making sure progress reports are submitted by researchers in time for ethics and regulatory renewals.
• Setting reminders for progress report deadlines on all studies following initial ethical approval and progress report approval.
• Tracking responses from ethics committees and regulatory agencies.
• Creating and maintaining checklists and SOPs
• Compiling printing records for project billing purposes
• Generating monthly work plans and activity reports
• Managing the MLW document control system and coordinating with departmental document controllers across MLW.
• Updating the submissions database for ethics and regulatory matters.
• Organising ethics study documents chronologically in the RG folder for every study.
• Ensuring monitoring reports are distributed within specified timelines.
• Promoting best practices by offering advice and guidance on research governance, including induction for new staff/PIs and managing GCP training records
• Arranging and delivering training sessions for MLW staff
• Monitoring compliance of MLW research projects
• Design and implement QA methods and procedures for research work.
• Carry out regular internal checks/audits and quality assurance reviews to ensure adherence to regulations and protocols
• Assess and review research paperwork, such as consent forms, case report forms, and data gathering instruments
• Coordinate and conduct training programs based on the CRSU calendar and specific study needs.
• Create training resources and hold refresher courses to address emerging quality issues.
• Produce and distribute training certificates to participants.
• Represent the RGA whenever needed.
• Foster effective communication and working relationships with both internal teams and external partners and collaborators.

• BSC in laboratory sciences, nursing, Clinical Medicine, pharmacy or related field.