endTB clinical trial:
- Undergo training in the protocol, trial procedures, and GCP.
- Oversee the medical officers and trial team to ensure participants are identified, recruited and enrolled in accordance with the potentially eligible rifampicin-resistant TB patients for the trial.
- Discuss clinical problems with the site Principal Investigator, and prepare reports for the trial Clinical Advisory Committee (CAC) where appropriate.
- Engage with clinic staff and other members of the team to identify medical problems or difficulty with adherence to study drugs.
- Liaise with clinic staff, including doctors, nurses, and counsellors/treatment coordinators, to share and discuss clinical progress of trial participants.
- Maintain regular contact with clinic doctors regarding the recruitment and management of trial participants. This includes writing and responding to referral letters to other clinicians/hospitals where required.
- Travel to other sites where the endTB Clinical Trial is actively managing patients for eg. Karachi/Mirpurkhas or any other site in Interior Sindh
- Compile and review reports on Serious Adverse Events (SAE), Adverse Events of Specific Interest (AESI) and communicate these to the trial pharmacovigilance unit and local regulatory authorities (together with the Clinical Manager, Site Coordinator and Site Principal Investigator).
- Develop clinical flows and work on weekly/monthly/quaterly plans for the clinic in coordination with the clincal team and other teams based within the clinic and present to other teams.
- Closley work with the pharmacy to assist in its development as per the demand of the clinic and the patients needs.
- They will examine, manage and treat patients seen in the TB clinics according to WHO & NTP/CDC guidelines
- Create treatment regimens for patients DR-TB and DOTS/DS-TB patient in consultation with Clinical Coordinator according to WHO and NTP guidelines
- Recording forms for DRTB and TB as required. Ensure that the entry of data is accurate.
- Write up complete progress and consultation notes on the relevant hard copy forms for follow-up and new MDRTB patients
- Write up complete progress and consultation notes on all follow-up patients seen on the HMIS
- They will report to clinical team leader for patient care, and discuss complex patients
- They will be responsible for generating timely lab testing request for follow-up and new patients according to the gudelines.
- Any decision that is different from what is documented by the NTP and the WHO guidelines will be clearly documented with reasoning for future auditing purposes and needs to be cleared by the clinical, lab and program team leaders.
- Coordinate with Clinical Quality Assurance Officer to ensure that protocols are followed and timely reporting of issues and incidents is recorded.
- Participate in clinical meetings, make case presentations actively implement protocols at there designated sites.