Job Description
The incumbent is to support the medical care and safety of the rifampicin-resistant TB patients participating in a phase III randomized controlled trial. They will be responsible to perform trial procedures in accordance with the protocol and Good Clinical Practice (GCP). The incumbent may also be responsible for managing staff, oversee patient care and ensuring adherence to established policies and procedures. S/he is charged with assigning staff and monitoring their activities, and with helping to recruit and train new personnel.
- Undergo training in the protocol, trial procedures, and GCP.
- Meets nursing operational standards by contributing information; implementing quality, and customer-service standards; resolving problems; identifying system improvements.
- Assuring quality of care and following up on work results
- Provides information to patients and health care team by answering questions and requests.
- Travel to trial clinic sites in Karachi.
- Engage with clinic staff, and assist endTB trial staff and counsellors to identify and recruit potentially eligible patients for the trial.
- Screen and enroll participants according to specific protocol and SOP requirements.
- Conduct informed consent for the main trial and sub-studies, together with counsellors.
- Provide counselling and treatment support to trial participants, together with counsellors.
- Liaise with clinic staff, including doctors, nurses, and counsellors, to share and discuss clinical and social progress of trial participants.
- Administer trial medication to study participants.
- Perform Directly Observed Therapy (DOT) and assess adherence according to trial SOPs.
Conduct trial procedures at screening, baseline, and follow up visits according to the trial protocol. These include, but are not limited to:
o Phlebotomy
o Physical examinations
o Electrocardiograms (ECGs)
o Screening tests for drug toxicity
· Complete Case Report Forms and other trial documents.
· Maintain participants’ clinical files, and perform Quality Assurance (QA) and Quality Control (QC).
· Assist with data entry and management.
· Engage with clinic staff and other members of the endTB trial team to identify medical problems or difficulty with adherence to study drugs.
· Assist with additional tasks as agreed upon with study management
· Attend regular meetings with the endTB trial team.