Kyrgyzstan: STUDY MANAGER In Osh

The endTB (Evaluating New Drugs for multidrug-resistant TB) clinical trial is an international multicentre 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), Epicentre (Paris, France) and is funded by UNITAID. The trial will be implemented in Georgia, Kazakhstan, Kyrgyzstan, Lesotho, and Peru.

In Kyrgyzstan the trial will take place in the district of Karasuu in the Osh region which is supported by MSF-OCG for diagnosis and treatment of multidrug resistance tuberculosis. The trial is coordinating by a trial manager based in Boston with PIH with support of a study coordinator from Epicentre based in Geneva for the two MSF sites in Georgia and Kyrgyzstan.

Job summary

•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.

•Will support, facilitate and coordinate daily clinical trial activities and play a critical role in the conduct of the study.

•Will work in collaboration with Clinical Trial team on site, the 2 site principal investigators in Bishkek and Osh, the MSF teams, the Central Clinical Trial team of the endTB trial and all relevant institutions (Ethics Committee and Regulatory Authorities) on the implementation and conduct of the endTB trial

Job description

During the trial preparation, the site study coordinator will:

-Review and ensure conformity with local requirements and GCP requirements all trial documents relevant to the site, including the study protocol, case report form (CRF), the patient information leaflet, informed consent form (ICF) etc.

-Assist the Site Principal Investigator (PI) in preparation and submission application and obtaining all necessary approvals from the relevant government authorities (MOH, ERC, NRA)

-Participate in the identification and recruitment of the trial site staff -Organize the training of the trial site staff on study procedures and pharmacovigilance (PV) with support from the MSF PV unit and the MSF study coordinator

-Coordinate the facility preparedness with the project logistician and with the support from the trial logistician

-Coordinate with the site pharmacist and with the support of the trial pharmacist that all study drugs are available and labelled according to the trial procedure before site opening

-Ensure that quality assurances are in place according to the requirements from the laboratory coordinator from ITM (Antwerp, Belgium) for TB laboratories and with other laboratories for clinical lab tests.

-Initiate the Trial Master file according to Good Clinical Practices (GCP)

-Ensure that all the trial Standard Operating Procedures (SOP), protocol, study documents are translated in Russian and available on site

-Verify with the site data manager and the trial data manager the preparedness of the site for the trial data management

-Initiate the Investigator Site File (ISF) and ensure that all essential documents to start recruitment are filled in the TMF

-Coordinate with the MSF study coordinator and the trial manager the site initiating monitoring visit

During recruitment in the trial:

-Provide assistance to ensure that the study is conducted, documented and reported according to the protocol, SOPs, GCP, and applicable international and national regulations.

-Support team in recruitment, enrollment, research data collection, maintaining study regulatory binder, ongoing monitoring of compliance with study protocol and all applicable local and institutional regulations.

-Collaborate and support the Site PIs in preparation and submission of reportable adverse events to the MSF PV unit, trial Central Team, local authorities, and relevant committees.

-Provide support to clinical investigators with subject recruitment in accordance with protocol, related SOP and based on GCP and applicable local regulatory requirement;

-Supervise in collaboration with the internal monitor that the investigators are compliant with the GCP regulations, particularly in ethical issues and in agreement with protocol and related SOPs;

-Monitor the progress of the study and prepare monthly progress report;

-Support the site PI for the submission of any amendment to protocol or ICFs for approval to local Regulatory Authorities and Ethical Committee bodies;

-Ensure data is recorded, handled, stored and reported accurately and promptly on CRFs and confidentiality is maintained;

-Provide patient’s data (case report form (CRF) pages, SAEs and other notifiable events) and screening log to Central Team and external monitor or any audit, when required;

-Review and ensure consistency with local requirements and GCP requirements of all trial documents relevant to the site, including the study protocol, CRF, the patient information leaflet, informed consent form etc.

-Ensure that all essential documents are filled in the TMF.

-Ensure with the pharmacist that study drugs are available at dispensing site according to trial schedule, and that drug accountability is organized on recruitment site and at the pharmacy.

-Be in constant communication with the Site PI and Co-PI, MSF study coordinator and Central Trial Team and the for: study updated, safety issues, any related to protocol deviation, any specific concern related to human specimen analysis, any request of study related document amendment

Position

•Will be part of the MSF project team in Osh under the supervision of the project field coordinator.

•Will work under the supervision of the trial MSF study coordinator from Epicentre based in Geneva, in close collaboration with the MSF medical coordinator in Bishkek, the MSF PV unit in Geneva and the trial manager in Boston. Candidate requirements
•Therapeutic trial experience as research assistant, study coordinator or study monitor.
•Comprehensive knowledge and understanding of clinical research regulations pertaining to human subjects protection and GCP
•Proficient in Microsoft Office applications, internet applications, Electronic Medical Records
•Must have superior communication and interpersonal skills, time management and problem solving skills
•Good knowledge of English and Russian is desirable
•International working experience, especially in limited resource countries and knowledge of tuberculosis clinical practices are preferable

Conditions Based in MSF-OCG Osh, Kyrgyzstan MSF- contract starting from 1st October 2015. 3 years positon with a minimum requirement of 1 year contract

Please, could you send your application (CV, Motivation letter) to:

magali.beurrier@geneva.msf.org, Recruitment and pool management- medical profiles Medecins sans Frontières Suisse

Only selected applications will receive an answer.