Clinical Trial Coordinator/Study Clinician at Malawi Liverpool Wellcome Trust

Introduction

The Malawi-Liverpool-Wellcome (MLW) Programme is an internationally recognized centre for research and research training, funded by the Wellcome Trust. MLW conducts internationally excellent research in areas within Clinical & Experimental Medicine, Infection Biology, Maternal, Neonatal & Child Health, Population Health, Social Sciences, and Vaccines, with the aim of tackling health and wellbeing challenges in Malawi and beyond. MLW also seeks to nurture and train the next generation of researchers and leaders in public health, providing them with access to excellent funding, facilities, and partnerships.

Job Summary:

The purpose of this post is to work in a team with clinical, laboratory and administrative staff colleagues, providing day-to-day oversight of specified Experimental Medicine studies including the BREATHE study of high flow oxygen in breathless patients.  Future human infection studies may include pneumococcal challenge, BCG challenge and perhaps viral co-infections. The successful candidate will coordinate a team of mixed cadres including research clinical officers and nurses and be responsible for patient recruitment, conduct of the clinical study and data management. The incumbent will provide independent team leadership, technical and logistic support, and management of the study teams, and will be supported in their role by the Principal Investigator and the study doctor/clinical Lead.

 

Key Responsibilities

The post-holder will provide day-to-day oversight of experimental medicine studies, maintain standards, develop academic outputs and be the main point of contact for the group head.

 

Study oversight

To lead and to be responsible for the coordination of the study activities.  This role will include such duties as:

1. Be available to provide advice and support to the study clinical and research nurses regarding their duties for the study, to ensure study requirements are fulfilled.
2. To monitor screening and recruitment progress and to provide regular updates to the study PI.
3. To liaise with the Heads of the Department of Medicine, and AETC at the Queen Elizabeth Central Hospital to identify any issues related to the conduct of the study and to provide them with periodic updates of progress.
4. To review, check and correct all documentation on enrolled study participants prior to entry into study database.
5. Provide training and oversight to the study nurses working on the study.
6. Take supervisory responsibility for staff management (including performing staff appraisals) and supervision and coordinating staff timetable and duty rosters and monitor overtime
7. Organise and participate in study team meetings to evaluate and plan study activities.
8. To oversee the maintenance of study equipment.
9. Arrange procurement of study supplies and ensure stock levels are maintained.
10. Maintain an amicable working relationship and clear communications with government Officials and Hospital Staff and other MLW staff.

Maintaining standards

Maintain a high standard in undertaking study activities.  This includes such tasks as:

1. Ensure that every potentially eligible participant is identified and screened promptly on arrival in study settings such as AETC, wards 3B and 4A (at the Queen Elizabeth Central Hospital), and all that are eligible are invited to participate following appropriate consent procedures.
2. Ensure all the requirements of the study are fulfilled according to the Standard Operating Procedures (SOPs) and the study protocol.
3. Ensure study documentation is completed accurately and according to the set SOPs and study protocol.
4. Ensure that all quality control procedures detailed in the study SOPs are adhered to fully.
5. Maintain professional education, including attending seminars and meetings both external and internal.
6. To maintain data on selected key performance indicators to include in the regular updates to the Principal Investigator and stakeholders.
7. Be proactive in identifying, reporting, and dealing with challenges in the conduct of l inter-related clinical studies.
8. Communicate professionally with hospital patients/study participants and their relatives, with other clinical staff, with staff from other studies, and with supervisors.
9. Adhere to the highest standards of ethics, of professional practice, and to the standards of Good Clinical Practice of the International Conference on Harmonisation for clinical research studies.
10. Liaise with several institutional review boards and ethics committees in Malawi, in the United States of America. Be responsible for updating and maintaining study regulatory documents.
11. Scheduling and chairing study management and study team staff meetings, including drawing agenda for such meetings, production and keeping meeting minutes.
12. Producing regular data and quality assurance monitoring reports to the PI and international coordinating investigator
13. Liaise with MLW departments like Clinical Research Support Unit for the conduct of the audit

Academic, clinical, strategic and administrative

The successful appointee will have the opportunity to develop a clinical and academic career, as well as giving input to the group strategy and developing administrative skills by carrying out activities such as:

1. Maintaining clinical activity and continuing professional development (CPD).
2. Preparation of manuscripts for publication
3. Development of new project ideas and draft grant applications.
4. Job analysis and hiring of relevant staff in liaison with the Clinical Lead and or principal investigator
5. Staff appraisal and making relevant recommendations to the human resource office in liaison with relevant principal investigators
6. Instituting internal controls for the effective and efficient use of resources.
7. Timely ordering of supplies for smooth running of study activities.

Others

Undertake all other reasonable tasks as requested by the study team members, group head, project coordinator or co-investigators as may be required from time to time.

All staff are employed under the MLW Programme and are ultimately responsible to the Programme whether directly employed under the Core Grant, a Research Fellowship or project grant. All staff are expected to be flexible and may be required to contribute to the activities of the Core Programme or other projects.

 

Health & Safety

As per MLW policy, all employees are responsible for Health and Safety by:

• Taking full responsibility for ensuring a safe work environment and following health and safety rules at all times for colleagues and oneself.
• Keeping up to date and maintain awareness of all Health and Safety issues by;
• Attending the scheduled quarterly Health & Safety sensitization trainings at least Once a year
• Attend a Health and safety induction during the first week of employment, signing acknowledgement and keep abreast of the MLW Health and Safety Policies and their updates
• Participate in Risk management exercises
• Bring to discussion all H&S matters observed/experienced during work and meetings
• Be available to assist when there is an emergency.
• To immediately notify the Line Manager of all Accidents/incidents and potential hazards/near misses and to complete the MLW Incident Report Form.

 Error of Judgment: failure to abide by the Health & Safety protocols and putting one-self, colleagues and Stakeholders at risk and failure to attend 1 Health & Safety session a year, will lead to disciplinary action.

Minimum Credentials:

1. Experience in clinical hospital practice and some postgraduate training. (Bachelor of Nursing/Midwifery or Diploma in Clinical Medicine or Bachelor of Medicine/Surgery or equivalent) with subsequent completion Master of Public Health or MSc or equivalent.
2. Experience managing clinical research projects.
3. Experience in data management and Good Clinical Practice.
4. Excellent communication skills
5. Demonstrated effective team leadership and management of staff

Additional desirable attributes:

1. Training and experience in clinical trial co-ordination
2. Excellent managerial skills and experience in effective, supportive supervision.
3. Attention to detail and demonstrated ability to manage complex challenges.

Accountability:                 Group Head, Prof Stephen Gordon

Liaises with:                       Lead nurse, study nurses, data staff, Hospital departmental heads of departments, MoH nurses, hospital clerks, MARVELS study staff, international staff.

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 job performance and other set criteria.

MLW recognizes its responsibility in safeguarding and protecting 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.

Method Of Application

Suitably qualified candidates should forward their applications with copies of relevant certificates, 3 contactable referees and a detailed CV to this email vacancies@mlw.mw. Please indicate the position title as the heading of your email. Hand-delivered applications will not be processed.

 To arrive no later than the 27 January 2023, only short-listed candidates will be acknowledged.