Lead Physician for MARVELS programme

Specific duties

Responsibilities include.

1. Clinical coordination of the MARVELS CHIM studies, ensuring quality communication between the study staff, the research governance teams and operational and administrative support staff (working closely with Neema Toto as MARVELS project coordinator).
2. Assist the PI to ensure communication with stakeholders in Malawi and abroad.
3. Oversee the MARVELS team of clinical, nursing, and other research support staff based at MLW/QECH in the day-to-day running of the trial.
4. Deliver out of hours on call services to study participants (including nights and weekends) to monitor and ensure safety within the programme.
5. Ensure all MARVELS programme procedures are conducted in accordance with the approved trial protocols, prescribed standard operating procedures (SOPs) and international good clinical practice (GCP) guidelines.
6. Ensure good clinical practice is maintained in all MARVELS related activities including screening, enrolment, clinical care, laboratory tests, procedures, follow-up of patients, accurate documentation and reporting of clinical and research findings.
7. Oversee and participate in research activities where needed, including eligibility screening, obtaining informed consent, enrolment, clinical care and follow up of study participants.
8. Review Case Report Forms and source documents on study screening, enrolment, follow-up and withdrawal to ensure rigour and readiness for trial monitoring procedures.
9. Check and communicate results of laboratory procedures (including but not limited to pneumoniae carriage and SARS-CoV-2 results) with relevant stakeholder to ensure participant safety and maintain study integrity.
10. Liaise with the Sponsor-assigned Medical Expert/Safety monitor in reviewing results of laboratory and. other investigations of potentially eligible candidates and enrolled study participants.
11. Ensure prompt reporting of serious adverse events and adverse events of special interest in accordance with the prescribed standard operating procedures and study protocol.
12. Assist in providing medical care to non-study participants as per agreement. Some of the duties associated with the post will involve 30% clinical contribution to the Department of Medicine, focused on the high dependency unit setting. While conducting clinical duties outside the MARVELS programme, the post holder will be responsible to the medical heads of department (College of Medicine and Ministry of Health). The post holder will be expected to undertake any clinical duties assigned by these supervisors, which may include participating in teaching/supervision of undergraduate and postgraduate students as well as interns and attend appropriate clinical and research meetings when possible.

Managerial

1. Overall clinical and research staff management & supervision.
2. Monitor recruitment progress and navigate safe study delivery in consultation with laboratory teams.
3. Conducting performance appraisals for staff under direct supervision.
4. Maintain an amicable working relationship and clear communications with government Officials, the Hospital Staff and the local community.
5. Participate in weekly research team meetings and work closely with the MARVELS Coordinator to deliver programme objectives.

Professional

1. Ensure study participants receive excellent care, are made to feel welcome by the study team and that meticulous attention to safety procedures are applied.
2. Always behave professionally.
3. Ensure maintenance of confidentiality of study participants’ records and respect the privacy and rights of participants.
4. Ensure staff maintain infection prevention and control procedures (including but not limited to SARS-CoV-2) at all times according to MLW, ward and hospital protocols.
5. Always put study participants’ interests first.
6. Keep clear and up-to date records of study participants at all times.
7. Adhere to standards of Good Clinical Practice (GCP) at all times.
8. At all times, be aware of responsibilities pertaining to the post (as recorded in this document) and other SOP’s.

Health and Safety

1. In liaison with MLW and QECH Health and Safety teams, take a leading role in ensuring the maintenance of a safe workplace environment by monitoring and enforcing strict adherence to Health and Safety protocols for all staff, through conducting spot checks, evaluations, staff induction and continuous training/professional development.
2. Ensure all trial staff are trained and up to date with GCP/GCLP (Laboratory).
3. Ensure all trial staff attend the quarterly scheduled Health and Safety sensitizations at least once a year, and that Health and safety Inductions are done for all new staff.
4. Ensure Health and Safety makes part of staff objectives to be reviewed during appraisals.
5. Maintain records and accurate documentation of all Health and Safety issues including actions taken, follow up with relevant departments and submitting Accident reports to the H&S Officer.
6. Support staff to gain immediate access to a physician for PEP and counselling following occupational accidents or exposure to infectious/noxious agents.

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 another project(s).