Reports to: PIH-Lesotho Site Study Coordinator and MDR-TB Program Director
The endTB (Evaluating New Drugs for multidrug-resistant TB) clinical trial is an international multicenter randomized therapeutic trial to evaluate short oral drug regimens for treatment of multidrug resistant tuberculosis. The trial is a collaborative project among Partners in Health (PIH, Boston USA), Harvard Medical School (HMS, Boston USA), Médecins Sans Frontières (MSF, Paris, France [OCP] and Geneva, Switzerland [OCG]), the Institute of Tropical Medicine (ITM, Antwerp, Belgium) and Epicentre (Paris, France), the Institute of Research for Development (IRD, Montpelier, France) and is funded by UNITAID. The trial will be implemented in in Georgia, Kazakhstan, Kyrgyzstan, Lesotho, and Peru.
Mission and responsibilities
In accordance with the ICH GCP E6 Guideline “Good Clinical Practice” sponsor of a clinical trial should assure that the rights and well-being of human subjects are protected, by ensuring that the reported trial data are accurate, complete, and verifiable from source documents, and assure that the trial is conducted in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). This task is realized through monitoring of clinical trials as a part of complex Quality Control and Quality Assurance activities. Within the framework of Quality Control activities, the ISM will support Principal Investigator and Site Study Coordinator in assuring that clinical trial is compliant with the International Conference of Harmonization Good Clinical Practice (ICH-GCP), study protocol and all applicable regulatory and Ethics Committee requirements. S/he will work closely with the site(s) and PIH Lesotho trial management team.
The ISM will:
● Be familiar with and understand the ethical standards and regulatory obligations that govern human subjects’ research;
● Ensure the protection of the rights, safety, and welfare of all study participants and safety of study staff;
● Oversee completion of study activities per protocol and effective standard operating procedures (SOPs);
● Act as liaison between study sponsor, collaborating organizations and/or other research institutions.
● Four year bachelor’s degree in Social Science or Health Science, plus 2 years of Quality Control or Quality Assurance activities.
● Knowledge and understanding of research ethics and clinical research regulations pertaining to human subjects’ protection.
● Proficiency in Microsoft Office applications and internet applications. Experience with electronic medical records and/or data capturing systems is desired
● Good organizational skill and meticulous attention to details
● Good knowledge of English and local language(s) (desirable)
Applications and detailed CVs may be hand delivered to PIHL offices at House 233, Cr Lancers and Caldwell road, Maseru west or emailed to email@example.com not later than 4th August 2017, or Apply here!
Only shortlisted candidates will be contacted.