Trial Coordinator

ob Description
Introduction

The Malawi-Liverpool-Wellcome (MLW) Programme (http://www.mlw.mw) is an internationally recognized centre for research and research training, funded by the Wellcome Trust. In collaboration with the Kamuzu University of Health Sciences (KUHeS), College of Medicine. MLW would like to engage the services of a competent and dynamic individual to work in an exciting Research Programme (Active Prevention and Treatment of Maternal Sepsis – APT SEPSIS Study) at  the MLW Research facility as it is expanding.

Position: Trial Coordinator – 1 post, based in Blantyre (initial 1 year contract)

Job Summary

To coordinate activities for an International Collaboration to Implement and Evaluate at Scale the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis). The trial will be implemented in 30 health facilities in Malawi. The key responsibility of the post holder is to coordinate with the CI’s and Co-Investigators, the Project Manager, the Host Institution and Sponsor to ensure that the trial is conducted in accordance with the study protocol and procedures, GCP and regulatory requirements and that the collected data are accurate and valid.

General Tasks

Prepare and track submissions to the relevant Research Ethics Committees and Regulatory Authority and ensure appropriate approval has been obtained for all trial related activities.
Assist the PIs and project manager in the description, definition and preparation of source
documents.
Ensure all essential documents are in place and updated as required, ensure document control.
Writing of individual SOPs as appropriate. Ensure all study SOPs are in place and ensure document control of all study SOPs.
Assist the CIs, PIS, and project manager to review the protocol for completeness, accuracy, and improvement opportunities.
Assists PIs to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with regulations and sponsoring agency policies and procedures
Work with the PI and study finance manager in monitoring study accounts and the study budget.
Assist the CI, PIs and project manager to oversee the conduct of clinical research in accordance
with GCP, Regulatory Authority and sponsoring agency policies and procedures.
Organise, attend and document meetings or events relevant to the start-up, conduct and closure of the trial.
Prepare for Study Site Initiation.
Assist with Community Awareness Initiatives.
Organise, participate and document staff trainings and ensure key personnel have met training requirements.
Oversee the day-to-day coordination of the trial.
Assist the project manager to oversee operational, administrative and HR matters.
Assist in the maintenance and development of a trial database to track trial participant’s progress through the trial, and monitor follow-up and participant adherence
Ensure trial statistics are maintained to monitor trial recruitment targets, and subject retention figures.
Assist the CI, PIs and project manager in checking data for errors and ensuring answering and
documentation of any queries raised.
Ensure adequate quality control and quality assurance systems are in place.
Preparation for, and facilitation of, monitoring visits, audits and/or inspections.
Facilitate communication between study sites, and MLW, ensure that all clinical trial data is collected, recorded, and processed to agreed timelines, in accordance with ICH GCP and as specified in the study protocol.
Assist with the notification and reporting of Serious Adverse Events to Sponsor, or relevant
Research Ethics Committees and Regulatory Authority, as appropriate.
Keep appraised of current legislation/guidelines and best practice. Disseminate as appropriate
to the PI and Investigator team.
Participate in weekend and out of hours working/stand by cover as part of the senior management rota.
Prepare for Study closure and archiving of essential documents in accordance with local
policy.

Qualifications

Minimum of a Master’s Degree in Clinical Trials, Public health and/or Clinical Medicine.
Should have at least 5 years’ experience in the Management and Conduct of Clinical Trials

Skills, General and Special knowledge

Passionate to improve Women’s health in Malawi and will participate in advocacy around
preventing and better treating maternal infections
Have an understanding and interest of implementation science, mixed methods research and
cluster randomized trials
Knowledge of and compliance with national standards of clinical governance and audit
Excellent organizational and co-ordination skills
Articulate with outstanding verbal and written communication skills
Flexible but with good time management and team working skills
Excellent records management and document control experience

Remuneration and Benefits

MLW offers an attractive remuneration package which includes a competitive salary package commensurate with the position, a medical aid scheme, 24 hours insurance cover, pension scheme, gratuity benefits redeemable once every year, among others. MLW also offers opportunities such as scholarships, upgrading and training opportunities to employees. These are based on successful on job performance and other set criteria.

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

How to apply

Suitably qualified candidates should forward their applications with copies of relevant certificates, 3 contactable referees and a detailed CV to this email:

Email: [email protected]

The Human Resource Manager

Malawi-Liverpool –Wellcome Trust

P.O. Box 30096

Chichiri

BLANTYRE 3

To arrive no later than the 21st October 2021, only short-listed candidates will be acknowledged