Job Description
The incumbent will provide quality medical care to eligible rifampicin-resistant TB patients of a phase III randomized controlled, and to conduct trial procedures in accordance with the protocol and Good Clinical Practice (GCP).
- Undergo training in the protocol, trial procedures, and GCP.
- Engage with clinic staff, and assist endTB trial staff and counsellors to identify and recruit potentially eligible rifampicin-resistant TB patients for the trial.
- Together with a research nurse, perform screening procedures for potential participants to assess eligibility for the trial.
- Together with a research nurse, perform trial follow up visits and associated procedures in accordance with the protocol and GCP.
- Prescribe study drugs, ancillary drugs, and antiretroviral agents (if needed) to trial participants.
- Perform medical assessments at every trial visit (and at unscheduled visits) to monitor clinical progress and to assess for adverse events.
- Perform medical assessments and follow up visits of trial participants in hospital when necessary.
- Assist research nurses with trial procedures, including phlebotomy, ECGs, toxicity screening.
- Complete Case Report Forms and other trial documents.
- 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, 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 where required.
- Travel to trial clinic sites in Karachi.
- Compile reports on serious adverse events, and communicate these to the trial pharmacovigilance unit and local regulatory authorities (together with the Trial Coordinator and site Principal Investigator)
- Assist with quality control and data entry and management.
- Attend regular meetings with the endTB trial team.
- To perform inpatient management required for good patient care for PMDT and trial patients.
- For inpatients: To update PMDT Clinical team or Clinical Trial team on clinical status, all investigations and lab results, and management of Trial patients on a daily basis.
- For inpatients: To consult with the PMDT Clinical team or Clinical Trial team for any changes to TB / ARV medication.
- To fill in any source worksheets for the clinical trial (CRFs) when required for inpatients.
- Fill in any necessary documentation for PMDT.
- As well as SAE reports, to send comprehensive discharge summaries for all inpatients, to include all relevant test results from investigations, imaging reports, drugs prescribed and other management given as inpatient.