Internal Monitor
- Shoklo Malaria Research Unit
- Nonprofits / องค์กรไม่แสวงหาผลกำไร
- 1473
- 23 Mar 2022
- 06 April 2022
The Shoklo Malaria Research Unit (SMRU) is a field station of the faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand, and is part of the Mahidol-Oxford Research Unit (MORU) supported by the Wellcome Trust, UK. The main objective of SMRU is to provide quality health care to the marginalised populations living on both sides of the Thai-Myanmar border in the Mae Sot area, Tak province. This is achieved by the dual activities of research and humanitarian services, with an emphasis on maternal-child health and infectious diseases.
SMRU is based in Mae Sot where the main laboratories are based and received samples from sites along the Thai-Myanmar border.
The post holder is based at the SMRU office in Mae Sot and is normally required to travel to other sites.
Job title: Internal Monitor
Location: Mae Sot based with frequently travel to clinics/sites
Probation: SMRU can terminate employment at 3 months if performance inadequate
Report to: Principal investigators
Tasks and Responsibilities (Monitoring 100%)
Main objective
- Provide quality monitoring of CRFs, blood samples, microscopy slides and source document linkage
- Work and communicate directly with principal investigator (PI) or sub-investigator of each study
- Work with clinic and study staff to monitor studies
- Respect the procedures and policies of the clinic and SMRU and the staff in all aspects of the work
Participating in study preparation
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- Review and understand the protocol
- Create document for study monitoring requirements in agreement with investigator
- Give training before starting study with clinic staff and/or study staff
Monitoring
- Comply with good clinical practice (GCP) guidelines
- Monitoring of CRFs, blood samples and microscopy slides
- Compare CRF with source documents
- Help organize sample storage with investigator and lab (i.e. slides need to be stored by code because it is easier to check)
- Carefully and precisely document monitoring results using checklists and templates. Make check list for site staff for checking CRF’s that will be sent to internal monitor, train staff to use
- Check drug accountability records
- Monitor studies in a timely manner
- Collaborate with clinics and/or study staff to help with monitoring
- Work with laboratory staff to clean blood samples and microscopy slides
- Work with IT team: Coordinate and organize data entry on a regular basis
Reporting
- Provide study reports at the request of the investigator
Technical support
- Monitor drug availability and drug expiration centrally and at the sites
- Maintaining study documents at each site remain in stock with correct version numbers
Coordination meetings
- Organize a monitoring meeting 3-4 months basis including investigators, monitors, IT, Lab and site teams
- Attend administration meetings at Mae Sot
- Attend meetings or trainings outside Mae Sot (i.e. Bangkok, or outside Thailand)
- Liase with external monitors as required
Monitoring competence
1. External training for monitoring provided by the Clinical Trials Support Group (CTSG) or by self-learning
Modules
Qualifications and Experience:
- Education in health-related disciplines, or a field related to research compliance
- Previous working experience in clinical trial study with monitoring experience
- Understand fluctuations in work load are an expected part of monitoring work
- Excellent communication skills
- Good skills in English and Thai, including fluency in local ethnics’ languages, e.g. Karen and Burmese.
- Experience and familiarity with Microsoft Word, Excel and Outlook.
- Excellent organizational skills with high attention to detail is required
- Ability to work effectively in teams as well as independently
- Ability to manage multiple projects at a time
How to apply
Applications must be sent to SMRU/HR Department 68/30 Bantung Road, Mae Sot, Tak 63110 or email to smru-hr@shoklo-unit.com
Dead line for application: 6th April 2022
Please note that only short-listed candidates will be notified for the interview process.