Vacancy: Clinical trial coordinator - Uzbekistan

1. Identification

Job Title:	Clinical Trial Coordinator
Reports to:	Project Coordinator
Reports to (functional) :	Mission level: Medical Coordinator HQ level:  Clinical Trial Manager
Area:	Operational
Supervises (function):	Medical activity manager, Lab quality manager, Qualified translator
Mission/Project:	Tashkent CT project
Budget Code:	P1102
Start date:	04 Jan 2022
End date:	03 Jan 2023
Annexes:

Project specifications

Project background

HIV letter to staff

 

2. Main purpose

To facilitate and manage the local relationship between the sponsor (MSF) and the clinical trial site (MOH) and to ensure that the trial is conducted in compliance with the trial protocol, the trial Standard Operating Procedures (SOPs), ICH Good Clinical Practice (GCP) and national regulatory requirements.

2a. Generic job accountabilities

Operational management / site coordination

• In close collaboration with MOH, continuously define resources required including medical material, logistic, human and financial resources.
• If needed, follow-up on the upgrading of the clinical laboratory to Good Clinic Laboratory Practice (GCLP) standards and on the set-up of a robust back-up lab system which also complies with GCLP standards.
• In coordination with the  MOH CRC, follow-up with training requirement for new hire working for TB Practecal as well as organize additional trainings as needed throughout the duration of the  trial.
• Planning and supervising, in close coordination with the HR department, the associated processes (recruitment, training, performance evaluation, development and internal communication) of the staff under his/her responsibility in order to improve staff capabilities and to ensure both the sizing and the amount of knowledge required.
• Support international MSF staff and the trial MoH staff to complete all trial activities
• In collaboration with the rest of the MSF Sponsor site team, monitor all aspects of trial conduct and assure that the trial is being conducted in compliance with Good Clinic Practice (GCP), applicable regulatory requirements, the trial protocol, and the trial SOPs
• Closely follow progress of the trial as per agreed project timelines
• Participate in the implementation of the community engagement strategy as well as sub-studies linked to TB Practecal.

Study documents

• Support the development, finalisation and signature of all local trial agreements
• Support the development/correction of clinical trial documents
• Ensure and support the site to collect study essential documents and to maintain the Investigator Site File
• Support the MSF staff in ensuring the site maintains trial logs (screening and recruitment log, drug accountability log, trial specimens log, etc.)

Logistics & Supply:

• Coordinate trial site physical upgrading activities as required
• Prepare medical & non-medical orders in collaboration with the Project Log manager, the HQ Trial team (Trial Pharmacist , Trial Lab Coordinator) and MOH stock managers
• Supervise management of the MSF drug supply and medical equipment
• In close collaboration with the logistics team, coordinate maintenance and service needs of laboratory, medical and IT equipment

Data

• In collaboration with the CMTL and the MSF Staff. Ensure timely entry and accurate submissions of study data in eCRF system
• Ensure the site provides sufficient security and confidentiality of participants' paper and electronic data
• Support MoH PI and his/her team in addressing queries raised by Data Management and / or Monitoring team as appropriate

Monitoring, audits & close out

• Prepare for, facilitate and attend monitoring visits
• Prepare for and attend audits and inspections
• Ensure and support the site PI to address all issues raised during monitoring visits, audits and inspection
• Support study closure activities including preparation and collection of close-out documentation and preparation of study files for archiving

Communication / oversight

• Maintain a well-working communication and collaboration system between the MOH CT site, the MSF Sponsor Site team, the Project, and the MSF HQ team
• Support the site PI to ensure reporting of any potential protocol violations/deviations to the Sponsor in a timely manner
• Act as a focal person to answer and /or seek advice from PMT on non-medical questions related to the trial

Project management:

• Report weekly to the MSF HQ team & prepare monthly reports on the MSF CT activities as needed by the mission
• Prepare Annual plan documents including project proposal revisions, budget, planning & reporting documents

2b. Job accountabilities - field focus

• Collaborate closely with the site CRC & CT ML to define resources required.
• Collaborate and coordinate with PC regarding the overall management and administration of the trial.
• In collaboration with HQ trial team, provide and/or facilitate GCP, protocol, trial SOPs and Electronic Case Report Form (eCRF) training for site staff
• Make sure trial-related documents are updated and well understood by respective trial team members with the support of CRC.
• Support the site PI and delegate to ensure reporting of any potential protocol violations/deviations to the Sponsor in a timely manner
• Support the site to implement the PRO and EE studies and organize meeting with sub-studies PI when necessary
• Make sure any safety report is submitted to regulatory authorities on time and file in ISF.
• Update global recruitment tracker for Tashkent site at SharePoint weekly. Complete monthly medical report, contribute monthly trial dashboard
• Attend biweekly site-specific meeting, and OST meeting
• Assist site in site closeout activities, including providing support for database lock, facilitating site closeout visit, return of trial equipment and trial documents archival
• Assist MSF team and site in bridging over to operational research to roll out trial arm to larger population

3. Requirements

3a. Fixed requirements

Education	Degree in healthcare-related discipline, or other degree with equivalent work experience
Experience	Essential: Experience in clinical trials for at least two years Desirable: Certification in Clinical Research
Languages	Essential: English language Willingness to learn Russian
Knowledge	Essential: Good Clinical Practice (GCP) and applicable regulations as exemplified by recent GCP certification. Essential: Computer literacy (word, excel and internet)

3b. Additional (flexible) requirements

Education	Medical doctor preferable
Experience	Project and people management
Languages	Fluent in English, knowledge of Russian is an asset
Knowledge	Familiarity with clinical trial administration and management procedures

3c. Competencies

	1	2	3	4
Strategic Vision		X
Planning & Organising			X
Teamwork & Cooperation				X
Leadership		X
People Management & Development			X

3d. Competencies (Field focus)

• Diplomatic and effective negotiation skills
• Attention to detail and accuracy
• Strong management skills
• Communication

Apply

To apply, send your CV to Brigitte Daubeny by 5pm GMT, Tuesday 15 February 2022.